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510(k) K222038

Device
CentriMag™ Blood Pump For Use With CentriMag™ Acute Circulatory Support System
Applicant
Abbott (formerly Thoratec Corporation)
510(k) number
K222038
Product code
QNR  
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-08
Date received
2022-07-11
Regulation
870.4100
Classification name
Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Meera Mehta
Address
6035 Stoneridge Dr. Pleasanton CA US 94588 94588

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250199VitalFlow ConsoleMedtronic, Inc.2025-05-20
K234118CentriMag™ Acute Circulatory Support SystemABBOTT MEDICAL2024-01-26
K233736LifeSPARC SystemCardiacassist, Inc.2024-01-19
K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)2023-08-25
K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)2023-08-25
K211830LifeSPARC SystemCardiacassist, Inc.2022-11-15
K202751TandemHeart Pump and Escort ControllerCardiacassist, Inc.2021-03-26

Legacy Summary#

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FDA Review#

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