510(k) K121536 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
| Applicant | Sorin Group Italia S.R.L., Arvada CO, US |
| Decision | Substantially Equivalent, Aug 22, 2012 |
| Received | May 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121536
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.