510(k) K964284 ยท DTK Filter, Intravascular, Cardiovascular
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jan 6, 1997 |
| Received | Oct 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2007 | Boston Scientific Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lot #7826572 Terminated |
DTK | None listed |
| Dec 23, 2005 | Boston Scientific Scimed Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Terminated |
DTK | None listed |
| Dec 20, 2005 | Boston Scientific Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Order No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use Terminated |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.