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FDA 510(k)

VitalFlowTM Centrifugal Pump

K-Number: K223898 · 2023-08-25

Decision Date2023-08-25
Product CodeQNR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalFlowTM Centrifugal Pump 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 K223898. 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 VitalFlowTM Centrifugal Pump?

VitalFlowTM Centrifugal Pump 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 K223898.

When was VitalFlowTM Centrifugal Pump approved by the FDA?

VitalFlowTM Centrifugal Pump received FDA 510(k) clearance on 2023-08-25, under approval number K223898.

What company makes VitalFlowTM Centrifugal Pump?

VitalFlowTM Centrifugal Pump is manufactured by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.).

What is the FDA product code for VitalFlowTM Centrifugal Pump?

The FDA product code for VitalFlowTM Centrifugal Pump is QNR.

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

Related Devices (Code: QNR)

Official Source

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