510(k) K141762 ยท FMF Syringe, Piston
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 27, 2014 |
| Received | Jul 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2016 | Biomet, Inc. PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression. Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.