FDA 510(k)

VitalFlow Console

K-Number: K230364 · 2023-08-25

ApplicantMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

Decision Date2023-08-25

Product CodeQNR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VitalFlow Console is a medical device manufactured by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). It received FDA 510(k) clearance on 2023-08-25 under approval number K230364. The device is classified under product code QNR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalFlow Console?

VitalFlow Console is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). The 510(k) number is K230364.

When was VitalFlow Console approved by the FDA?

VitalFlow Console received FDA 510(k) clearance on 2023-08-25, under approval number K230364.

What company makes VitalFlow Console?

VitalFlow Console is manufactured by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.).

What is the FDA product code for VitalFlow Console?

The FDA product code for VitalFlow Console is QNR.

Other Devices by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

K223898VitalFlowTM Centrifugal Pump

Related Devices (Code: QNR)

K202751TandemHeart Pump and Escort ControllerCardiacassist, Inc. K222038CentriMag Blood Pump for use with CentriMag Acute Circulatory Support SystemAbbott (Formerly Thoratec Corporation) K211830LifeSPARC SystemCardiacassist, Inc. K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) K234118CentriMag Acute Circulatory Support SystemABBOTT MEDICAL K233736LifeSPARC SystemCardiacassist, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.