VitalFlow Console
FDA 510(k) clearance K250199 · decided 2025-05-20
Clearance details
- K-number
- K250199
- Device name
- VitalFlow Console
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-23
- Decision date
- 2025-05-20
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- QNR
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| CentriMag™ Acute Circulatory Support System (K234118) | ABBOTT MEDICAL | 2024-01-26 |
| LifeSPARC System (K233736) | Cardiacassist, Inc. | 2024-01-19 |
| VitalFlow™ Console (K230364) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| VitalFlowTM Centrifugal Pump (K223898) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (K222038) | Abbott (Formerly Thoratec Corporation) | 2022-12-08 |
| LifeSPARC System (K211830) | Cardiacassist, Inc. | 2022-11-15 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MC3 VitalFlow Console, REF 58100; Blood pump of ecmo recall (Z-0509-2026) | Medtronic Perfusion Systems | 2025-11-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |