FDA 510(k) Applications for Medical Device Product Code "QNR"

FDA 510(k) Number Applicant Device Name Decision Date
K222038 Abbott (formerly Thoratec Corporation) CentriMagÖ Blood Pump for use with CentriMagÖ Acute Circulatory Support System 12/08/2022
K234118 Abbott Medical CentriMagÖ Acute Circulatory Support System 01/26/2024
K233736 CardiacAssist, Inc. LifeSPARC System 01/19/2024
K211830 CardiacAssist, Inc. LifeSPARC System 11/15/2022
K202751 CardiacAssist, Inc. TandemHeart Pump and Escort Controller 03/26/2021
K250199 Medtronic Inc VitalFlow Console 05/20/2025
K230364 Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) VitalFlowÖ Console 08/25/2023
K223898 Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) VitalFlowTM Centrifugal Pump 08/25/2023


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