510(k) K052302 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Sep 12, 2005 |
| Received | Aug 24, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2020 | Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - 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-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occl Terminated |
MAL | None listed |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Platinum Woven Double Velour TAAA 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.