510(k) K180979 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
PureFlex Arterial Cannulae
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Apr 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180979
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.