Cleared Special

K042399 - MODIFICATION TO SHORT INTRODUCER SHEATH

K042399 is an FDA 510(k) clearance for MODIFICATION TO SHORT INTRODUCER SHEATH, manufactured by Rex Medical, L.P.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 105-day FDA review.

K042399 · Rex Medical, L.P. · Cardiovascular device
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Dec 2004
Decision
105d
Days
Class 2
Risk

K042399 is an FDA 510(k) clearance for the MODIFICATION TO SHORT INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Rex Medical, L.P. (Great Neck, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 105 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rex Medical, L.P. devices

FDA 510(k) Submission Details - K042399

510(k) Number K042399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2004
Decision Date December 17, 2004
Days to Decision 105 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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 435
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K042399.
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · Thomas Medical Products, Inc. · Feb 2005
INTRAVASCULAR ACCESS INTRODUCER SHEATH
K041506 · Applied Medical Resources Corp. · Oct 2004
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
K040728 · AngioDynamics, Inc. · Jun 2004