510(k) K122254 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
| Applicant | Sorin Group Italia S.R.L., Arvada CO, US |
| Decision | Substantially Equivalent, Aug 24, 2012 |
| Received | Jul 27, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122254
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.