Cleared Special

K013202 - MODIFICATION TO BRAIDED GUIDING INTRODUCER

K013202 is the FDA 510(k) clearance for MODIFICATION TO BRAIDED GUIDING INTRODUCER by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 28-day FDA review.

K013202 · Thomas Medical Products, Inc. · Cardiovascular device
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Oct 2001
Decision
28d
Days
Class 2
Risk

K013202 is an FDA 510(k) clearance for the MODIFICATION TO BRAIDED GUIDING INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on October 23, 2001 after a review of 28 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Thomas Medical Products, Inc. devices

Submission Details

510(k) Number K013202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date October 23, 2001
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 373
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K013202.
RENAL GUIDING SHEATH
K012854 · Terumo Medical Corp. · Nov 2001
CAROTID GUIDING SHEATH
K012812 · Terumo Medical Corp. · Nov 2001
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
K011761 · Arrow Intl., Inc. · Oct 2001
SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515
K013029 · St Jude Medical · Oct 2001
VYGON SPLIT CANNULA INTRODUCER
K010913 · Vygon Corp. · Sep 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · St Jude Medical · Sep 2001