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FDA 510(k)

VitalFlowTM Centrifugal Pump

K-Number: K223898 · 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

VitalFlowTM Centrifugal Pump is the device name listed in this FDA 510(k) record. The listed applicant is Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). It received FDA 510(k) clearance on 2023-08-25 under 510(k) 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. The listed applicant is Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). The 510(k) number is K223898.

When did VitalFlowTM Centrifugal Pump receive FDA 510(k) clearance?

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

Who is the listed applicant for VitalFlowTM Centrifugal Pump?

The FDA 510(k) record lists Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitalFlowTM Centrifugal Pump?

The FDA product code for VitalFlowTM Centrifugal Pump is QNR.

Other records listing Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230364VitalFlow™ Console

Related Devices (Code: QNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250199VitalFlow ConsoleMedtronic, Inc.K234118CentriMag™ Acute Circulatory Support SystemABBOTT MEDICALK233736LifeSPARC SystemCardiacassist, Inc.K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemAbbott (Formerly Thoratec Corporation)K211830LifeSPARC SystemCardiacassist, Inc.

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.

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