510(k) K072091 ยท DTZ Oxygenator, Cardiopulmonary Bypass
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Oct 29, 2007 |
| Received | Jul 30, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K072091
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.