510(k) K241352 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jun 12, 2024 |
| Received | May 13, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241352
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2025 | Medtronic Perfusion Systems Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B Open, Classified |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.