Cleared Special

K112697 - CHARGER PTA BALLON DILATATION CATHETER

K112697 is the FDA 510(k) clearance for CHARGER PTA BALLON DILATATION CATHETER by Boston Scientific. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 75-day FDA review.

K112697 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
75d
Days
Class 2
Risk

K112697 is an FDA 510(k) clearance for the CHARGER PTA BALLON 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 November 30, 2011 after a review of 75 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 K112697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2011
Decision Date November 30, 2011
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
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 K112697.
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · Cordis Corp. · May 2012
GLADIATOR PTA BALLOON DILATION CATHETER
K113681 · Boston Scientific · Jan 2012
ATB ADVANCE PTA DILATATION CATHETER
K113300 · Cook, Inc. · Dec 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · Boston Scientific Corporation · May 2011
MUSTANG BALLOON DILATATION CATHETERS
K103751 · Boston Scientific · Mar 2011
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
K103464 · Medtronic, Inc. · Dec 2010