Cleared Traditional

K050629 - ANGIOSCULPT SCORING BALLOON CATHETER

K050629 is an FDA 510(k) clearance for ANGIOSCULPT SCORING BALLOON CATHETER, manufactured by Angioscore, Inc.. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K050629 · Angioscore, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
175d
Days
Class 2
Risk

K050629 is an FDA 510(k) clearance for the ANGIOSCULPT SCORING BALLOON CATHETER. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Angioscore, Inc. (Alameda, US). The FDA issued a Cleared decision on September 2, 2005 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K050629

510(k) Number K050629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2005
Decision Date September 02, 2005
Days to Decision 175 days
Submission Type Traditional
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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 45
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K050629.
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
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387 · Boston Scientific · Oct 2006
PERIPHERAL CUTTING BALLOON
K051254 · Boston Scientific Ivt · Jun 2005
2 CM PERIPHERAL CUTTING BALOON
K041993 · Boston Scientific Ivt · Aug 2004
PERIPHERAL CUTTING BALLOON
K040155 · Boston Scientific Corp · Jul 2004
K050629 · ANGIOSCULPT SCORING BALLOON CATHETER
Download PDF FDA Summary Angioscore, Inc.