510(k) K040163 ยท MVR Device, Anastomotic, Microvascular
MICROVASCULAR ANASTOMOTIC DEVICE
| Applicant | Synovis Micro Companies Alliance, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Apr 16, 2004 |
| Received | Jan 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2008 | Synovis Micro Companies Alliance Inc GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized
This is a microsurgical coupler used in the anastomosis of veins and arteries no Terminated |
MVR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.