FDA 510(k)

CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System

K-Number: K222038 · 2022-12-08

ApplicantAbbott (Formerly Thoratec Corporation)

Decision Date2022-12-08

Product CodeQNR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System is a medical device manufactured by Abbott (Formerly Thoratec Corporation). It received FDA 510(k) clearance on 2022-12-08 under approval number K222038. 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 Blood Pump for use with CentriMag Acute Circulatory Support System?

CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System is a medical device that received FDA 510(k) clearance on 2022-12-08. It is manufactured by Abbott (Formerly Thoratec Corporation). The 510(k) number is K222038.

When was CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System approved by the FDA?

CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System received FDA 510(k) clearance on 2022-12-08, under approval number K222038.

What company makes CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System?

CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System is manufactured by Abbott (Formerly Thoratec Corporation).

What is the FDA product code for CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System?

The FDA product code for CentriMag Blood Pump for use with 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: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) 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)

Other Devices by Abbott (Formerly Thoratec Corporation)

K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

Related Devices (Code: QNR)

K202751TandemHeart Pump and Escort ControllerCardiacassist, Inc. 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.) K234118CentriMag Acute Circulatory Support SystemABBOTT MEDICAL K233736LifeSPARC 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.