Cleared Special

COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

K002591 · Cobe Cardiovascular, Inc. · Cardiovascular
Sep 2000
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K002591 is an FDA 510(k) clearance for the 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 September 13, 2000, 23 days after receiving the submission on August 21, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.

Submission Details

510(k) Number K002591 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2000
Decision Date September 13, 2000
Days to Decision 23 days
Submission Type Special
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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