FDA-Device2020-05-13Class II
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Maquet Cardiovascular, LLC
Hazard
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
Affected count
N/A
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1861-2020Don't want to check this manually?
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