Cleared Special

CentriMag? Acute Circulatory Support System

K234118 · Abbott Medical · Cardiovascular

Jan 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K234118 is an FDA 510(k) clearance for the 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 Medical (Pleasanton, US). The FDA issued a Cleared decision on January 26, 2024, 29 days after receiving the submission on December 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K234118 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2023
Decision Date	January 26, 2024
Days to Decision	29 days
Submission Type	Special
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.