510(k) K222038 · QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
| Applicant | Abbott (Formerly Thoratec Corporation), Pleasanton CA, US |
| Decision | Substantially Equivalent, Dec 8, 2022 |
| Received | Jul 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2026 | Thoratec LLC CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016;
CentriMag RVAD HDE KIT, REF: 104318;
CentriMag Pre-connected Pack, REF: CMAEK00;
CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-9 Open, Classified |
QNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.