510(k) K121229 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Jul 23, 2012 |
| Received | Apr 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121229
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.