Cleared Traditional

COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

K004046 · Cobe Cardiovascular, Inc. · Cardiovascular
Apr 2001
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K004046 is an FDA 510(k) clearance for the COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, a Defoamer, Cardiopulmonary Bypass (Class II — Special Controls, product code DTP), submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on April 26, 2001, 118 days after receiving the submission on December 29, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.

Submission Details

510(k) Number K004046 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2000
Decision Date April 26, 2001
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTP — Defoamer, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4230

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