510(k) K191252 ยท MVR Device, Anastomotic, Microvascular
Gem FlowCoupler System
| Applicant | Baxter/ Synovis Micro Companies Alliance, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jul 9, 2019 |
| Received | May 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191252
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2023 | Baxter Healthcare Corporation GEM FLOW COUPLER Monitor, PN 5156-00000-011 Open, Classified |
DPW | None listed |
| Dec 28, 2020 | Baxter Healthcare Corporation FLOW COUPLER Monitor
Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm).
Implantable device for vascular use. Open, Classified |
MVR | None listed |
| Jun 2, 2020 | Baxter Healthcare Corporation Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only Open, Classified |
MVR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.