Cleared Abbreviated

SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG

K050111 · Cobe Cardiovascular, Inc. · Cardiovascular
Mar 2005
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K050111 is an FDA 510(k) clearance for the SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG, 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 March 8, 2005, 49 days after receiving the submission on January 18, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K050111 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2005
Decision Date March 08, 2005
Days to Decision 49 days
Submission Type Abbreviated
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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