Cleared Traditional

LANCASTER COOLING JACKET, CAT. CODE #13500/13501

K913077 · Dlp, Inc. · Cardiovascular
Jan 1992
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K913077 is an FDA 510(k) clearance for the LANCASTER COOLING JACKET, CAT. CODE #13500/13501, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 9, 1992, 182 days after receiving the submission on July 11, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K913077 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1991
Decision Date January 09, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

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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