Cleared Special

K113681 - GLADIATOR PTA BALLOON DILATION CATHETER

K113681 is the FDA 510(k) clearance for GLADIATOR PTA BALLOON DILATION CATHETER by Boston Scientific. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 27-day FDA review.

K113681 · Boston Scientific · Cardiovascular device
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Jan 2012
Decision
27d
Days
Class 2
Risk

K113681 is an FDA 510(k) clearance for the GLADIATOR PTA BALLOON DILATION 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 January 11, 2012 after a review of 27 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 K113681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2011
Decision Date January 11, 2012
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 224
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K113681.
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
K121856 · C.R. Bard, Inc. · Jul 2012
AMPHIRION PLUS PTA CATHETER
K121265 · Medtronic, Inc. · May 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · Cordis Corp. · May 2012
ATB ADVANCE PTA DILATATION CATHETER
K113300 · Cook, Inc. · Dec 2011
CHARGER PTA BALLON DILATATION CATHETER
K112697 · Boston Scientific · Nov 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · Boston Scientific Corporation · May 2011