FDA-Device2022-06-29Class II
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
Maquet Cardiovascular, LLC
Hazard
Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
Sold states
US Nationwide distribution in the state of SC.
Affected count
1 unit
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1282-2022Don't want to check this manually?
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