Cleared Special

SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800

K033641 · Cobe Cardiovascular, Inc. · Cardiovascular
Dec 2003
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K033641 is an FDA 510(k) clearance for the SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on December 11, 2003, 21 days after receiving the submission on November 20, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K033641 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2003
Decision Date December 11, 2003
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTN — Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4400

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