Devices

Device Recall Zilver 518 Vascular Self Expanding Stent

Model / Serial
Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide distribution: USA (nationwide) and country of: Japan.
Product Description
Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Manufacturer
Cook Ireland Ltd.
1 Event
- Recall of Device Recall Zilver 518 Vascular Self Expanding Stent

Manufacturer

Cook Ireland Ltd.

Manufacturer Address
Cook Ireland Ltd., O'holloran Road,, National Technological Park, Limerick, Peroc Ireland
Manufacturer Parent Company (2017)
Cook Group Incorporated
Source
USFDA

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