Cleared Special

K141112 - STERLING OVER-THE WIRE PTA BALLOON DILA...

K141112 is the FDA 510(k) clearance for STERLING OVER-THE WIRE PTA BALLOON DILA... by Boston Scientific. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 77-day FDA review.

K141112 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
77d
Days
Class 2
Risk

K141112 is an FDA 510(k) clearance for the STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on July 16, 2014 after a review of 77 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

Submission Details

510(k) Number K141112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2014
Decision Date July 16, 2014
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 216
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