VitalFlow Console
FDA 510(k) K230364 · Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
Submission
- Device name
- VitalFlow Console
- Applicant
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
Dexter, MI, US - Received
- February 10, 2023
- Decision date
- August 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNR – Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected…
Other 510(k)s with product code QNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250199 | VitalFlow ConsoleQNR · Traditional | Medtronic, Inc. | 05/20/2025SE |
| K234118 | CentriMag Acute Circulatory Support SystemQNR · Special | Abbott Medical | 01/26/2024SE |
| K233736 | LifeSPARC SystemQNR · Traditional | Cardiacassist, Inc. | 01/19/2024SE |
| K223898 | VitalFlowTM Centrifugal PumpQNR · Traditional | Michigan Critical Care Consultants, Inc. (D.B.A… | 08/25/2023SE |
| K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support SystemQNR · Traditional | Abbott (Formerly Thoratec Corporation) | 12/08/2022SE |
| K211830 | LifeSPARC SystemQNR · Traditional | Cardiacassist, Inc. | 11/15/2022SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | Cardiacassist, Inc. | 03/26/2021SE |
More from Cardiacassist, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K223898 | VitalFlowTM Centrifugal PumpQNR · Traditional | 08/25/2023SE |
Questions and answers
When was VitalFlow Console cleared by the FDA?
VitalFlow Console (K230364) received a 510(k) decision of Substantially Equivalent on August 25, 2023, 196 days after the submission was received.
What is the product code of K230364?
The FDA product code is QNR – Blood Pump For Ecmo, Long-Term (> 6 Hours) Use, a Class II (moderate risk) device regulated under 21 CFR 870.4100.