Cleared Special

K150634 - AngioSculpt PTA Scoring Baloon Catheters

K150634 is an FDA 510(k) clearance for AngioSculpt PTA Scoring Baloon Catheters, manufactured by Spectranetrics. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Special 510(k) pathway after a 28-day FDA review.

K150634 · Spectranetrics · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
28d
Days
Class 2
Risk

K150634 is an FDA 510(k) clearance for the AngioSculpt PTA Scoring Baloon Catheters. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Spectranetrics (Colorado Springs, US). The FDA issued a Cleared decision on April 8, 2015 after a review of 28 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. 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. Low regulatory complexity profile. 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 - K150634

510(k) Number K150634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2015
Decision Date April 08, 2015
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 Consultant

Spectranetics
Kimberley Kline

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 45
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K150634.
Serranator Alto PTA Serration Balloon Catheter
K163380 · Cagent Vascular, LLC · Feb 2017
FLEX SCORING CATHETER
K152789 · Venturemed Group · May 2016
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
K151253 · Boston Scientific Limited · Jun 2015
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
K150634 · AngioSculpt PTA Scoring Baloon Catheters
Download PDF FDA Summary Spectranetrics