510(k) K131618 ยท DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Sep 27, 2013 |
| Received | Jun 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131618
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.