510(k) K162843 ยท DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Oct 11, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162843
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.