Cleared Special

K082343 - VASCUTRAK 2, MODELS: V14 AND V18

K082343 is an FDA 510(k) clearance for VASCUTRAK 2, manufactured by Ymed, Inc.. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Special 510(k) pathway after a 27-day FDA review.

K082343 · Ymed, Inc. · Cardiovascular device
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Sep 2008
Decision
27d
Days
Class 2
Risk

K082343 is an FDA 510(k) clearance for the VASCUTRAK 2, MODELS: V14 AND V18. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Ymed, Inc. (San Diego, US). The FDA issued a Cleared decision on September 11, 2008 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Ymed, Inc. devices

FDA 510(k) Submission Details - K082343

510(k) Number K082343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2008
Decision Date September 11, 2008
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

PNO Device Classification - Class 2, Special Controls

Product Code PNO Catheter, Percutaneous, Cutting/scoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
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 - PNO Catheter, Percutaneous, Cutting/scoring

All 21
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K082343.
UltraScore Focused Force PTA Balloon
K163420 · Bard Peripheral Vascular, Inc. · Jun 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · Cook Incorporated · Mar 2015
VASCUTRAK PTA DILATATION CATHETER
K103459 · C.R. Bard, Inc. · Dec 2010
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
K070951 · Boston Scientific · Jun 2007
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387 · Boston Scientific · Oct 2006
PERIPHERAL CUTTING BALLOON
K040155 · Boston Scientific Corp · Jul 2004