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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 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 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. The listed applicant is Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). The 510(k) number is K230364.

When did VitalFlow™ Console receive FDA 510(k) clearance?

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

Who is the listed applicant for VitalFlow™ Console?

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 VitalFlow™ Console?

The FDA product code for VitalFlow™ Console 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.

K223898VitalFlowTM Centrifugal Pump

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.K223898VitalFlowTM Centrifugal PumpMichigan 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

View on FDA Database →

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

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