510(k) K200612 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Nov 17, 2020 |
| Received | Mar 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200612
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.