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CORDIS SABER™ .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter - HSA Registration DE0017174

Access comprehensive regulatory information for CORDIS SABER™ .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0017174 and owned by Cordis US Corp.. The device was registered on May 18, 2015.

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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CLASS D
DE0017174
CORDIS SABER™ .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
HSA Registration Number: DE0017174
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Product Description

The SABER .018 PTA catheter is indicated for enabling treatment of stenoses in the iliac, femoral, ilio-femoral, popliteal, and infra- popliteal arteries. The device is also indicated for post-dilation of balloon-expandable and self- expanding stents in the peripheral vasculature.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0017174
Registration Date
May 18, 2015
Change Notification Approval Date
March 14, 2025
Retention Due Date
May 17, 2025
Product Owner
Short Name
Cordis US Corp.
Address
14201 North West 60th Avenue, Miami Lakes, Florida 33014, Florida, 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)
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Model Identifier(s)
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