510(k) K021213 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Apr 19, 2002 |
| Received | Apr 17, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occl Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occl Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d Terminated |
MAL | None listed |
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di Terminated |
MAL | None listed |
| Aug 22, 2019 | GETINGE US SALES LLC The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascul Terminated |
MAL | None listed |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts. Terminated |
MAL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.