Cleared Traditional

BD INTROSYTE PRECISION INTRODUCER (K020834) - FDA 510(k) Clearance

Also marketed or referenced as:
BD INTROSYTE-N PRECISION INTRODUCER BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER BD I

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020834 · Becton Dickinson Infusion Therapy Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
90d
Days
Class 2
Risk

K020834 is an FDA 510(k) clearance for the BD INTROSYTE PRECISION INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on June 12, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton Dickinson Infusion Therapy Systems, Inc. devices

Submission Details

510(k) Number K020834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 279
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K020834.
EDWARDS INTRODUCER SHEATH
K031087 · Edwards Lifesciences, LLC · Apr 2003
SHEATH ADAPTER, MODEL SA-09847
K021723 · Arrow Intl., Inc. · Aug 2002
INTROCAN SAFETY IV CATHETER
K021094 · B.Braun Medical, Inc. · Jul 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · Edwards Lifesciences, LLC · Mar 2002
RENAL GUIDING SHEATH
K012854 · Terumo Medical Corp. · Nov 2001
CAROTID GUIDING SHEATH
K012812 · Terumo Medical Corp. · Nov 2001