Cleared Special

K151253 - 2cm Peripheral Cutting Balloon Microsur...

K151253 is the FDA 510(k) clearance for 2cm Peripheral Cutting Balloon Microsur... by Boston Scientific Limited. It is a Class 2 Cardiovascular device (product code PNO) cleared through the Special 510(k) pathway after a 29-day FDA review.

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 20
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K151253.
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K141322 · Cook Incorporated · Mar 2015
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K070951 · Boston Scientific · Jun 2007