510(k) K030836 ยท QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 17, 2003 |
| Received | Mar 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage Terminated |
FRO | None listed |
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Terminated |
FRO | None listed |
| Oct 4, 2005 | B. Braun Medical, Inc. D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.