510(k) K132727 ยท MVR Device, Anastomotic, Microvascular
GEM FLOW COUPLER DEVICE AND SYSTEM
| Applicant | Synovis Life Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 22, 2013 |
| Received | Sep 3, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-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), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC.
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-t Terminated |
DPW | None listed |
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-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), 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 |
| Jul 29, 2014 | Baxter Healthcare Corporation FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstr Terminated |
DPW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.