510(k) K202751 ยท QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
TandemHeart Pump and Escort Controller
| Applicant | Cardiacassist, Inc., Pittsburg PA, US |
| Decision | Substantially Equivalent, Mar 26, 2021 |
| Received | Sep 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202751
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.