Cleared Traditional

K063657 - VASCUTRAK PTA DILATION CATHETER

K063657 is an FDA 510(k) clearance for VASCUTRAK PTA DILATION CATHETER, manufactured by Ymed, Inc.. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K063657 · Ymed, Inc. · Cardiovascular device
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Dec 2006
Decision
4d
Days
Class 2
Risk

K063657 is an FDA 510(k) clearance for the VASCUTRAK PTA DILATION CATHETER. 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 December 12, 2006 after a review of 4 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ymed, Inc. devices

FDA 510(k) Submission Details - K063657

510(k) Number K063657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2006
Decision Date December 12, 2006
Days to Decision 4 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 125d · This submission: 4d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K063657.
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