VitalFlowTM Centrifugal Pump
FDA 510(k) K223898 · Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
Submission
- Device name
- VitalFlowTM Centrifugal Pump
- Applicant
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
Dexter, MI, US - Received
- December 28, 2022
- 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 |
| K230364 | VitalFlow ConsoleQNR · 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 |
|---|---|---|
| K230364 | VitalFlow ConsoleQNR · Traditional | 08/25/2023SE |
Questions and answers
When was VitalFlowTM Centrifugal Pump cleared by the FDA?
VitalFlowTM Centrifugal Pump (K223898) received a 510(k) decision of Substantially Equivalent on August 25, 2023, 240 days after the submission was received.
What is the product code of K223898?
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.