Cordis S.M.A.R.T.® Control™ and S.M.A.R.T.® Nitinol Stent Systems - HSA Registration DE0003942
Access comprehensive regulatory information for Cordis S.M.A.R.T.® Control™ and S.M.A.R.T.® Nitinol Stent Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0003942 and owned by Cordis Corporation. The device was registered on September 28, 2006.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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HSA Official Data
CLASS D
DE0003942
Cordis S.M.A.R.T.® Control™ and S.M.A.R.T.® Nitinol Stent Systems
HSA Registration Number: DE0003942
Product Description
Indicated for use in patients with atherosclerotic disease of peripheral arteries, including iliac and superficial femoral
Device Classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0003942
Registration Date
September 28, 2006
Change Notification Approval Date
September 18, 2024
Retention Due Date
August 09, 2025
Product Owner
Short Name
Cordis
Address
14201 North West 60th Avenue, Miami Lakes, Florida 33014, UNITED STATES
Registrant
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #05-01, SINGAPORE 188778
Importer
Address
5 TAI SENG DRIVE, SCA CREATIVE CENTRE, #02-01, SINGAPORE 535217
15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model Information
Model Name(s)
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 20mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 20mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 30mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 30mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 40mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 40mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 60mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 60mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 80mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 80mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 100mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 100mm; Diameter 6mm; Min/Max Diameter 4 to 5mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® Nitinol Stent System 6 mm X 120mm
Cordis S.M.A.R.T.® Nitinol Stent System 6 mm X 150mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 20mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 20mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 30mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 30mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 40mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 40mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 60mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 60mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 80mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 80mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 100mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 100mm; Diameter 7mm; Min/Max Diameter 5 to 6mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® Nitinol Stent System 7 mm X 120mm
Cordis S.M.A.R.T.® Nitinol Stent System 7 mm X 150mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 20mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 20mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 30mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 30mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 40mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 40mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 60mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 60mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 80mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 80mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 100mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 100mm; Diameter 8mm; Min/Max Diameter 6 to 7mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® Nitinol Stent System 8 mm X 120mm
Cordis S.M.A.R.T.® Nitinol Stent System 8 mm X 150mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 20mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 20mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 30mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 30mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 40mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 40mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 60mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 60mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 20mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 20mm; Diameter 9mm; Min/Max Diameter 7 to 8mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 20mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 20mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 30mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 30mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 40mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 40mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 60mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 60mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 80mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 80mm; Diameter 10mm; Min/Max Diameter 8 to 9mm; Sheath/Guiding Compatibility 6\8 F; Guidance acceptance 0.035"
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 20mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 20mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 30mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 30mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 40mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 40mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 60mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 60mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 80mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 80mm; Diameter 12mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 30mm; Diameter 14mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 30mm; Diameter 14mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 40mm; Diameter 14mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 40mm; Diameter 14mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 60mm; Diameter 14mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 60mm; Diameter 14mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 120mm; Stent Length 80mm; Diameter 14mm
Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent System Delivery System Length 80mm; Stent Length 80mm; Diameter 14mm
Model Identifier(s)
C06020MV
C06020SV
C06030MV
C06030SV
C06040MV
C06040SV
C06060MV
C06060SV
C06080MV
C06080SV
C06100MV
C06100SV
C06120MV
C06150MV
C07020MV
C07020SV
C07030MV
C07030SV
C07040MV
C07040SV
C07060MV
C07060SV
C07080MV
C07080SV
C07100MV
C07100SV
C07120MV
C07150MV
C08020MV
C08020SV
C08030MV
C08030SV
C08040MV
C08040SV
C08060MV
C08060SV
C08080MV
C08080SV
C08100MV
C08100SV
C08120MV
C08150MV
C09020MV
C09020SV
C09030MV
C09030SV
C09040MV
C09040SV
C09060MV
C09060SV
C09080MV
C09080SV
C10020MV
C10020SV
C10030MV
C10030SV
C10040MV
C10040SV
C10060MV
C10060SV
C10080MV
C10080SV
C12020MV
C12020SV
C12030MV
C12030SV
C12040MV
C12040SV
C12060MV
C12060SV
C12080MV
C12080SV
C14030MV
C14030SV
C14040MV
C14040SV
C14060MV
C14060SV
C14080MV
C14080SV