Cleared Special

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

K131964 · Medtronic, Inc. · Cardiovascular
Jul 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K131964 is an FDA 510(k) clearance for the BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on July 24, 2013, 27 days after receiving the submission on June 27, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K131964 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2013
Decision Date July 24, 2013
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWA — Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4380

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