Cleared Traditional

CentriMag? Blood Pump for use with CentriMag? Acute Circulatory Support System

K222038 · Abbott (Formerly Thoratec Corporation) · Cardiovascular

Dec 2022

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K222038 is an FDA 510(k) clearance for the CentriMag? Blood Pump for use with CentriMag? Acute Circulatory Support System, a Blood Pump For Ecmo, Long-term (> 6 Hours) Use (Class II — Special Controls, product code QNR), submitted by Abbott (Formerly Thoratec Corporation) (Pleasnaton, US). The FDA issued a Cleared decision on December 8, 2022, 150 days after receiving the submission on July 11, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K222038 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2022
Decision Date	December 08, 2022
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QNR — Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4100
Definition	A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure Where Other Available Treatment Options Have Failed And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.