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Edwards Lifesciences Fogarty Arterial Embolectomy catheters - HSA Registration DE0010474

Access comprehensive regulatory information for Edwards Lifesciences Fogarty Arterial Embolectomy catheters in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010474 and owned by Edwards Lifesciences LLC. The device was registered on September 10, 2012.

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 B
DE0010474
Edwards Lifesciences Fogarty Arterial Embolectomy catheters
HSA Registration Number: DE0010474
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Product Description

The Arterial Embolectomy Catheters are intended to be used for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDB00110
HS Code
90183910
Registration Information
Registration Number
DE0010474
Registration Date
September 10, 2012
Change Notification Approval Date
December 01, 2020
Retention Due Date
September 09, 2025
Product Owner
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Address
35 CHANGI NORTH CRESCENT, SINGAPORE 499641 5 TAI SENG DRIVE, SCA CREATIVE CENTRE, #02-01, SINGAPORE 535217 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model Information
Model Name(s)
Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Embolectomy Catheter with Gate Valve Accessory Set
Model Identifier(s)
120403F 120403FP 120403FS 120403FSP 120404F 120404FP 120602F 120602FP 120803F 120803FP 120803FS 120803FSP 120804F 120804FP 120805F 120805FP 120806F 120806FP 120807F 120807FP 12A0403F 12A0404F 12A0602F 12A0803F 12A0804F 12A0805F 12A0806F 12A0807F 12A1004F CV3200