510(k) K211830 ยท QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
LifeSPARC System
| Applicant | Cardiacassist, Inc., Pittsburg PA, US |
| Decision | Substantially Equivalent, Nov 15, 2022 |
| Received | Jun 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211830
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.