510(k) K233895 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 5, 2024 |
| Received | Dec 11, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233895
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.