Cleared Traditional

FIRST PICC INTRODUCER CATHETER

K954906 · Becton Dickinson Vascular Access, Inc. · Cardiovascular
Apr 1996
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K954906 is an FDA 510(k) clearance for the FIRST PICC INTRODUCER CATHETER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on April 8, 1996, 166 days after receiving the submission on October 25, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K954906 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1995
Decision Date April 08, 1996
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340