Cleared Special

COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

K984456 · Cobe Cardiovascular, Inc. · Cardiovascular
Jan 1999
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K984456 is an FDA 510(k) clearance for the COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, 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 January 11, 1999, 27 days after receiving the submission on December 15, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K984456 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1998
Decision Date January 11, 1999
Days to Decision 27 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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