Cleared Traditional

K122685 - ANGIOSCULPT PTA SCORING BALLOON CATHETER

K122685 is an FDA 510(k) clearance for ANGIOSCULPT PTA 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 133-day FDA review.

K122685 · Angioscore, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
133d
Days
Class 2
Risk

K122685 is an FDA 510(k) clearance for the ANGIOSCULPT PTA SCORING BALLOON CATHETER. 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 January 11, 2013 after a review of 133 days - within the typical 510(k) review window.

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 - K122685

510(k) Number K122685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2012
Decision Date January 11, 2013
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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 K122685.
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · Cook Incorporated · Mar 2015
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
K142983 · Angioscore, Inc. · Mar 2015
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
K133998 · Angioscore, Inc. · Apr 2014
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
K113103 · Rex Medical · May 2012
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K112182 · Angioscore, Inc. · Aug 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K110767 · Angioscore, Inc. · Apr 2011
K122685 · ANGIOSCULPT PTA SCORING BALLOON CATHETER
Download PDF FDA Summary Angioscore, Inc.