Cleared Special

K073025 - VASCUTRAK II PTA DILATATION CATHETER

K073025 is an FDA 510(k) clearance for VASCUTRAK II PTA DILATATION CATHETER, manufactured by Thermopeutix, Inc. Dba Ymed, Inc.. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Special 510(k) pathway after a 14-day FDA review.

K073025 · Thermopeutix, Inc. Dba Ymed, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
14d
Days
Class 2
Risk

K073025 is an FDA 510(k) clearance for the VASCUTRAK II PTA DILATATION CATHETER. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Thermopeutix, Inc. Dba Ymed, Inc. (San Diego, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 14 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.

FDA 510(k) Submission Details - K073025

510(k) Number K073025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2007
Decision Date November 09, 2007
Days to Decision 14 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
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 46
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K073025.
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K082059 · Angioscore, Inc. · Aug 2008
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
K081220 · Angioscore, Inc. · May 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
K080151 · Angioscore, Inc. · Apr 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K072225 · Angioscore, Inc. · Oct 2007
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
K070951 · Boston Scientific · Jun 2007
VASCUTRAK PTA DILATION CATHETER
K063657 · Ymed, Inc. · Dec 2006
K073025 · VASCUTRAK II PTA DILATATION CATHETER
Download PDF FDA Summary Thermopeutix, Inc. Db…