FDA 510(k)

CentriMag Acute Circulatory Support System

K-Number: K234118 · 2024-01-26

Decision Date2024-01-26

Product CodeQNR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CentriMag Acute Circulatory Support System is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-01-26 under approval 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. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K234118.

When was CentriMag Acute Circulatory Support System approved by the FDA?

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

What company makes CentriMag Acute Circulatory Support System?

CentriMag Acute Circulatory Support System is manufactured by ABBOTT MEDICAL.

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 PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025) PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

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Related Devices (Code: QNR)

K202751TandemHeart Pump and Escort ControllerCardiacassist, Inc. K222038CentriMag Blood Pump for use with CentriMag Acute Circulatory Support SystemAbbott (Formerly Thoratec Corporation) K211830LifeSPARC SystemCardiacassist, Inc. K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) K230364VitalFlow ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) K233736LifeSPARC 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.