Cleared Traditional

IV CATHETER AND OBTURATOR

K941429 · Becton Dickinson Vascular Access, Inc. · General Hospital
Jan 1995
Decision
286d
Days
Class 2
Risk

About This 510(k) Submission

K941429 is an FDA 510(k) clearance for the IV CATHETER AND OBTURATOR, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Becton Dickinson Vascular Access, Inc. (Nogales, Sonora, MX). The FDA issued a Cleared decision on January 4, 1995, 286 days after receiving the submission on March 24, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K941429 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1994
Decision Date January 04, 1995
Days to Decision 286 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOS — Catheter, Umbilical Artery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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