Cleared Traditional

BIO-CONSOLE 560

K080824 · Medtronic Perfusion Systems · Cardiovascular
May 2008
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K080824 is an FDA 510(k) clearance for the BIO-CONSOLE 560, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on May 7, 2008, 44 days after receiving the submission on March 24, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K080824 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2008
Decision Date May 07, 2008
Days to Decision 44 days
Submission Type Traditional
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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