Cleared Traditional

DISPOSABLE HEMOSTATIC Y-CONNECTORS

K113132 · Coeur, Inc. · Cardiovascular

Jan 2012

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K113132 is an FDA 510(k) clearance for the DISPOSABLE HEMOSTATIC Y-CONNECTORS, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on January 20, 2012, 88 days after receiving the submission on October 24, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K113132 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2011
Decision Date	January 20, 2012
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

Device Classification

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