Cleared Traditional

BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I

K020834 · Becton Dickinson Infusion Therapy Systems, Inc. · Cardiovascular
Jun 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K020834 is an FDA 510(k) clearance for the BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on June 12, 2002, 90 days after receiving the submission on March 14, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K020834 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2002
Decision Date June 12, 2002
Days to Decision 90 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

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