Cleared Traditional

BCD ADVANCED

K910923 · Shiley, Inc. · Cardiovascular
Apr 1991
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K910923 is an FDA 510(k) clearance for the BCD ADVANCED, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on April 9, 1991, 35 days after receiving the submission on March 5, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K910923 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1991
Decision Date April 09, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTR — Heat-exchanger, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4240

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