510(k) K033709 ยท QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 18, 2003 |
| Received | Nov 26, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033709
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat 2 Dry hemostatic ban Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.