510(k) K123387 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
QUIKCLOT HEMOSTATIC DRESSING
| Applicant | Z-Medica, LLC, Wallingford CT, US |
| Decision | Substantially Equivalent, Apr 12, 2013 |
| Received | Nov 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2017 | Z-Medica, LLC QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding woun Terminated |
FRO | None listed |
| May 17, 2017 | Z-Medica, LLC QuikClot TraumaPad, , sterile, soft, white, X-ray detectable
hemostatic dressing
Part Number 460
Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA
For use as a topica Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.