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Edwards Lifesciences Fogarty Corkscrew Catheters - HSA Registration DE0010469

Access comprehensive regulatory information for Edwards Lifesciences Fogarty Corkscrew 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 DE0010469 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
DE0010469
Edwards Lifesciences Fogarty Corkscrew Catheters
HSA Registration Number: DE0010469
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Product Description

The Fogarty Corkscrew Catheters are utilized for removal of emboli and thrombi from either native vessels or synthetic grafts in the arterial system.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0010469
Registration Date
September 10, 2012
Change Notification Approval Date
February 27, 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 Corkscrew Catheter Fogarty Corkscrew Catheter Fogarty Corkscrew Catheter
Model Identifier(s)
1408010 140806 140808