510(k) K143589 ยท MVR Device, Anastomotic, Microvascular
GEM Flow COUPLER Device and System
| Applicant | Synovis Life Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jan 16, 2015 |
| Received | Dec 18, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to- Terminated |
DPW | None listed |
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to Terminated |
DPW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.