Cleared Special

K062387 - SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM

K062387 is an FDA 510(k) clearance for SMALL PERIPHERAL CUTTING BALLON, manufactured by Boston Scientific. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Special 510(k) pathway after a 51-day FDA review.

K062387 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
51d
Days
Class 2
Risk

K062387 is an FDA 510(k) clearance for the SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 51 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 devices

FDA 510(k) Submission Details - K062387

510(k) Number K062387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2006
Decision Date October 05, 2006
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 34
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K062387.
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K110767 · Angioscore, Inc. · Apr 2011
VASCUTRAK PTA DILATATION CATHETER
K103459 · C.R. Bard, Inc. · Dec 2010
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
K070951 · Boston Scientific · Jun 2007
ANGIOSCULPT SCORING BALLOON CATHETER
K050629 · Angioscore, Inc. · Sep 2005
PERIPHERAL CUTTING BALLOON
K051254 · Boston Scientific Ivt · Jun 2005
2 CM PERIPHERAL CUTTING BALOON
K041993 · Boston Scientific Ivt · Aug 2004