510(k) K191029 · DTZ Oxygenator, Cardiopulmonary Bypass
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma R
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 17, 2019 |
| Received | Apr 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191029
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.