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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K063657.
VASCUTRAK II PTA DILATATION CATHETER
K073025 · Thermopeutix, Inc. Dba Ymed, Inc. · Nov 2007
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
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387 · Boston Scientific · Oct 2006
ANGIOSCULPT SCORING BALLOON CATHETER
K050629 · Angioscore, Inc. · Sep 2005
PERIPHERAL CUTTING BALLOON
K051254 · Boston Scientific Ivt · Jun 2005
K063657 · VASCUTRAK PTA DILATION CATHETER
Download PDF FDA Summary Ymed, Inc.