Cleared Traditional

BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER

K133130 · Cook, Inc. · Cardiovascular
Jan 2015
Decision
466d
Days
Class 2
Risk

About This 510(k) Submission

K133130 is an FDA 510(k) clearance for the BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 9, 2015, 466 days after receiving the submission on September 30, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K133130 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2013
Decision Date January 09, 2015
Days to Decision 466 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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