510(k) K132972 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 28, 2013 |
| Received | Sep 23, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2016 | Medtronic Inc Affinity Fusion" Oxygenator with Integrated Arterial Filter,
Affinity Fusion cardiotomy/Venous Reservoir,
Perfusion Tubing Packs
The Affinity Fusion Oxygenator with Integrated Arterial Filter with or Terminated |
DTZ | None listed |
| Dec 16, 2014 | Medtronic Perfusion Systems The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.