Devices

Device Recall InterGard Knitted Collagen Coated Vascular prostheses

  • Model / Serial
    Serial Number: 40246657, Lot number: 09M03.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - Arizona.
  • Product Description
    InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. || Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.
  • Manufacturer
    Intervascular S.A.S.
  • 1 Event

Manufacturer

Intervascular S.A.S.
  • Manufacturer Address
    Intervascular S.A.S., Zone Industrielle Athelia I, La Ciotat Cedex France
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen...
  • Model / Serial
    Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17  40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
  • Product Description
    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; || InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
  • Manufacturer
    Intervascular S.A.S.