Cleared Traditional

K042036 - AIRGUARD VALVED INTRODUCER

K042036 is the FDA 510(k) clearance for AIRGUARD VALVED INTRODUCER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K042036 · C.R. Bard, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
25d
Days
Class 2
Risk

K042036 is an FDA 510(k) clearance for the AIRGUARD VALVED INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 23, 2004 after a review of 25 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K042036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2004
Decision Date August 23, 2004
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Citech
JAMES MURPHY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K042036.
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INTRAVASCULAR ACCESS INTRODUCER SHEATH
K041506 · Applied Medical Resources Corp. · Oct 2004
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
K040728 · AngioDynamics, Inc. · Jun 2004
INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
K033527 · B.Braun Medical, Inc. · Feb 2004
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
K034061 · Boston Scientific Corp · Jan 2004