510(k) K190499 ยท MVR Device, Anastomotic, Microvascular
Gem FlowCoupler System
| Applicant | Baxter/ Synovis Micro Companies Alliance, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Sep 6, 2019 |
| Received | Mar 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190499
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.