510(k) K122844 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
| Applicant | Sorin Group Italia S.R.L., Arvada CO, US |
| Decision | Substantially Equivalent, Oct 17, 2012 |
| Received | Sep 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122844
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.