510(k) K142784 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Oct 24, 2014 |
| Received | Sep 26, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142784
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.