Cleared Traditional

K100303 - ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

K100303 is an FDA 510(k) clearance for ANGIOSCULPT PTA SCORING BALLOON CATHETE..., 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 47-day FDA review.

K100303 · Angioscore, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
47d
Days
Class 2
Risk

K100303 is an FDA 510(k) clearance for the ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXY.... Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Angioscore, Inc. (Fremont, US). The FDA issued a Cleared decision on March 22, 2010 after a review of 47 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 - K100303

510(k) Number K100303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2010
Decision Date March 22, 2010
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
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 K100303.
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K110767 · Angioscore, Inc. · Apr 2011
VASCUTRAK PTA DILATATION CATHETER
K103459 · C.R. Bard, Inc. · Dec 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
K101735 · Angioscore, Inc. · Jul 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
K091966 · Angioscore, Inc. · Jul 2009
VASCUTRAK 2, MODELS: V14 AND V18
K082343 · Ymed, Inc. · Sep 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K082059 · Angioscore, Inc. · Aug 2008
K100303 · ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY
Download PDF FDA Summary Angioscore, Inc.