Cleared Traditional

BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER

K913341 · C.R. Bard, Inc. · Gastroenterology & Urology
Jan 1992
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K913341 is an FDA 510(k) clearance for the BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER, a Catheter, Coude (Class II — Special Controls, product code EZC), submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 27, 1992, 185 days after receiving the submission on July 26, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K913341 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1991
Decision Date January 27, 1992
Days to Decision 185 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZC — Catheter, Coude
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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