FDA 510(k)

VitalFlow Console

K-Number: K250199 · 2025-05-20

Decision Date2025-05-20

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 Medtronic, Inc.. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250199. 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 2025-05-20. The listed applicant is Medtronic, Inc.. The 510(k) number is K250199.

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

VitalFlow Console received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250199.

Who is the listed applicant for VitalFlow Console?

The FDA 510(k) record lists Medtronic, 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.

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Related Devices (Code: QNR)

K234118CentriMag™ Acute Circulatory Support SystemABBOTT MEDICAL K233736LifeSPARC SystemCardiacassist, Inc.K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 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.