Cleared Traditional

ADVANCE CS CORONARY SINUS INFUSION CATHETER

K131204 · Cook, Inc. · Cardiovascular
Jan 2014
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K131204 is an FDA 510(k) clearance for the ADVANCE CS CORONARY SINUS INFUSION CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 29, 2014, 275 days after receiving the submission on April 29, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K131204 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2013
Decision Date January 29, 2014
Days to Decision 275 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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