Cleared Traditional

K021094 - INTROCAN SAFETY IV CATHETER

K021094 is an FDA 510(k) clearance for INTROCAN SAFETY IV CATHETER, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021094 · B.Braun Medical, Inc. · Cardiovascular device
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Jul 2002
Decision
90d
Days
Class 2
Risk

K021094 is an FDA 510(k) clearance for the INTROCAN SAFETY IV CATHETER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on July 3, 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K021094

510(k) Number K021094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2002
Decision Date July 03, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

DYB Device Classification - Class 2, Special Controls

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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K021094.
TITAN MICRO CATHETER, MODEL 105-5074-153
K022003 · Micro Therapeutics, Inc. · Sep 2002
MODIFICATION TO MEDAMICUS AXIA RSN
K022689 · Medamicus, Inc. · Aug 2002
SHEATH ADAPTER, MODEL SA-09847
K021723 · Arrow Intl., Inc. · Aug 2002
BD INTROSYTE PRECISION INTRODUCER
K020834 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2002
VALVED PEELABLE INTRODUCER
K021004 · Medamicus, Inc. · Jun 2002
MEDAMICUS AXIA RSN
K020563 · Medamicus, Inc. · May 2002