510(k) K061031 ยท DTZ Oxygenator, Cardiopulmonary Bypass
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 2, 2006 |
| Received | Apr 14, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061031
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.