Cleared Special

K151253 - 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151253 · Boston Scientific Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
29d
Days
Class 2
Risk

K151253 is an FDA 510(k) clearance for the 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Boston Scientific Limited (Galway, IE). The FDA issued a Cleared decision on June 10, 2015 after a review of 29 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.

View all Boston Scientific Limited devices

Submission Details

510(k) Number K151253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2015
Decision Date June 10, 2015
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 44
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K151253.
UltraScore™ Focused Force PTA Balloon
K260012 · Bard Peripheral Vascular, Inc. · Feb 2026
Aperta NSE PTA Balloon Dilatation Catheter
K243944 · Goodman Co., Ltd. · Apr 2025
D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
K242254 · Dk Medical Technology Co., Ltd. · Apr 2025
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
K241478 · Brosmed Medical Co., Ltd. · Oct 2024
XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
K232258 · Transit Scientific, LLC · Jun 2024
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
K232013 · Goodman Co., Ltd. · Mar 2024