Cleared Traditional

VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER

K874112 · Van-Tec, Inc. · Gastroenterology & Urology
Feb 1988
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K874112 is an FDA 510(k) clearance for the VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on February 11, 1988, 125 days after receiving the submission on October 9, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K874112 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1987
Decision Date February 11, 1988
Days to Decision 125 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KOD — Catheter, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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