Cleared Special

BIO-CONSOLE, MODEL 560

K051303 · Medtronic Perfusion Systems · Cardiovascular
Jun 2005
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K051303 is an FDA 510(k) clearance for the BIO-CONSOLE, MODEL 560, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Medtronic Perfusion Systems (Brooklyn Park, US). The FDA issued a Cleared decision on June 10, 2005, 22 days after receiving the submission on May 19, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K051303 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2005
Decision Date June 10, 2005
Days to Decision 22 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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