510(k) K112771 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
| Applicant | Sorin Group Italia S.R.L., Arvada CO, US |
| Decision | Substantially Equivalent, Oct 14, 2011 |
| Received | Sep 23, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112771
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.