Cleared Traditional

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)

K965214 · Coeur Laboratories, Inc. · Cardiovascular
Mar 1997
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K965214 is an FDA 510(k) clearance for the COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002), a Gas Control Unit, Cardiopulmonary Bypass (Class II — Special Controls, product code DTX), submitted by Coeur Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on March 28, 1997, 88 days after receiving the submission on December 30, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4300.

Submission Details

510(k) Number K965214 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1996
Decision Date March 28, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTX — Gas Control Unit, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4300

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