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FDA 510(k)

CentriMag™ Acute Circulatory Support System

K-Number: K234118 · 2024-01-26

ApplicantABBOTT MEDICAL
Decision Date2024-01-26
Product CodeQNR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CentriMag™ Acute Circulatory Support System is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K234118. 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 CentriMag™ Acute Circulatory Support System?

CentriMag™ Acute Circulatory Support System is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K234118.

When did CentriMag™ Acute Circulatory Support System receive FDA 510(k) clearance?

CentriMag™ Acute Circulatory Support System received FDA 510(k) clearance on 2024-01-26, under 510(k) number K234118.

Who is the listed applicant for CentriMag™ Acute Circulatory Support System?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentriMag™ Acute Circulatory Support System?

The FDA product code for CentriMag™ Acute Circulatory Support System is QNR.

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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.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.

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