FDA Product Code
FDA Product Code QNR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4100
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250199 | VitalFlow Console | Medtronic, Inc. | 2025-05-20 | Traditional | PDF ↗ |
| K234118 | CentriMag Acute Circulatory Support System | ABBOTT MEDICAL | 2024-01-26 | Special | PDF ↗ |
| K233736 | LifeSPARC System | Cardiacassist, Inc. | 2024-01-19 | Traditional | PDF ↗ |
| K223898 | VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 | Traditional | PDF ↗ |
| K230364 | VitalFlow Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 | Traditional | PDF ↗ |
| K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System | Abbott (Formerly Thoratec Corporation) | 2022-12-08 | Traditional | PDF ↗ |
| K211830 | LifeSPARC System | Cardiacassist, Inc. | 2022-11-15 | Traditional | PDF ↗ |
| K202751 | TandemHeart Pump and Escort Controller | Cardiacassist, Inc. | 2021-03-26 | Traditional | PDF ↗ |
Product code QNR · Class II · Cardiovascular. Data: openFDA.