Cleared Special

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700

K030462 · Cobe Cardiovascular, Inc. · Cardiovascular
Mar 2003
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K030462 is an FDA 510(k) clearance for the COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on March 6, 2003, 22 days after receiving the submission on February 12, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.

Submission Details

510(k) Number K030462 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2003
Decision Date March 06, 2003
Days to Decision 22 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4360

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