510(k) K162215 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jun 16, 2017 |
| Received | Aug 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162215
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.