Cleared Special

K132498 - VALVED TEARAWAY INTRODUCER GENERATION II

K132498 is an FDA 510(k) clearance for VALVED TEARAWAY INTRODUCER GENERATION II, manufactured by Medcomp (Medical Components, Inc.). The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 108-day FDA review.

K132498 · Medcomp (Medical Components, Inc.) · Cardiovascular device
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Nov 2013
Decision
108d
Days
Class 2
Risk

K132498 is an FDA 510(k) clearance for the VALVED TEARAWAY INTRODUCER GENERATION II. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medcomp (Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on November 25, 2013 after a review of 108 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 Medcomp (Medical Components, Inc.) devices

FDA 510(k) Submission Details - K132498

510(k) Number K132498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2013
Decision Date November 25, 2013
Days to Decision 108 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
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 434
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K132498.
CATHETER INTRODUCER SHEATH
K131627 · Edwards Lifesciences, LLC · Mar 2014
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K130633 · Oscor, Inc. · Feb 2014
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K132720 · Merit Medical Systems, Inc. · Feb 2014
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · Medtronic, Inc. · Sep 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · Merit Medical Systems, Inc. · Sep 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · Medical Components, Inc. · Aug 2013