Cleared Special

CentriMag Acute Circulatory Support System

K191557 · Thoratec Corporation (Now Part of Abbott) · Cardiovascular

Jul 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K191557 is an FDA 510(k) clearance for the CentriMag Acute Circulatory Support System, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Thoratec Corporation (Now Part of Abbott) (Pleasnaton, US). The FDA issued a Cleared decision on July 10, 2019, 28 days after receiving the submission on June 12, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number	K191557 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2019
Decision Date	July 10, 2019
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF