Cleared Special

K142983 - AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating

K142983 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 Special 510(k) pathway after a 139-day FDA review.

K142983 · Angioscore, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
139d
Days
Class 2
Risk

K142983 is an FDA 510(k) clearance for the AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating. 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 4, 2015 after a review of 139 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142983

510(k) Number K142983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2014
Decision Date March 04, 2015
Days to Decision 139 days
Submission Type Special
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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Modification to existing cleared device.

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 K142983.
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
K151253 · Boston Scientific Limited · Jun 2015
AngioSculpt PTA Scoring Baloon Catheters
K150634 · Spectranetrics · Apr 2015
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · Cook Incorporated · Mar 2015
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
K133998 · Angioscore, Inc. · Apr 2014
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K122685 · Angioscore, Inc. · Jan 2013
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
K113103 · Rex Medical · May 2012
K142983 · AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
Download PDF FDA Summary Angioscore, Inc.