Panels › Cardiovascular › Product code QNR · Class 2
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Regulation 870.4100
0510(k)s in 12 months (8 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in QNR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardiacassist, Inc. | 3 | 0 |
| Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2 | 0 |
| Abbott (Formerly Thoratec Corporation) | 1 | 0 |
| ABBOTT MEDICAL | 1 | 0 |
| Medtronic, Inc. | 1 | 0 |
| Medtronic Perfusion Systems | 0 | 1 |
| Thoratec LLC | 0 | 1 |
| 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 | K222038 |
| Nov 14, 2025 | Medtronic Perfusion Systems MC3 VitalFlow Console, REF 58100; Blood pump of ecmo Open, Classified |
QNR | K230364 K250199 |
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