Cleared Traditional

COLIGN

K131124 · Jilin Coronado Medical , Ltd. · Cardiovascular

Aug 2013

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K131124 is an FDA 510(k) clearance for the COLIGN, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Jilin Coronado Medical , Ltd. (Jilin, CN). The FDA issued a Cleared decision on August 28, 2013, 128 days after receiving the submission on April 22, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K131124 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2013
Decision Date	August 28, 2013
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4290