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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 2025 | K250199 | VitalFlow Console Medtronic, Inc. | QNR |
| Jan 26, 2024 | K234118 | CentriMag Acute Circulatory Support System ABBOTT MEDICAL | QNR |
| Jan 19, 2024 | K233736 | LifeSPARC System Cardiacassist, Inc. | QNR |
| Aug 25, 2023 | K230364 | VitalFlow Console Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | QNR |
| Aug 25, 2023 | K223898 | VitalFlowTM Centrifugal Pump Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | QNR |
| Dec 8, 2022 | K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System Abbott (Formerly Thoratec Corporation) | QNR |
| Nov 15, 2022 | K211830 | LifeSPARC System Cardiacassist, Inc. | QNR |
| Mar 26, 2021 | K202751 | TandemHeart Pump and Escort Controller Cardiacassist, Inc. | QNR |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.