Cleared Traditional

K103751 - MUSTANG BALLOON DILATATION CATHETERS

K103751 is the FDA 510(k) clearance for MUSTANG BALLOON DILATATION CATHETERS by Boston Scientific. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K103751 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
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Mar 2011
Decision
89d
Days
Class 2
Risk

K103751 is an FDA 510(k) clearance for the MUSTANG BALLOON DILATATION CATHETERS. 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 March 22, 2011 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific devices

Submission Details

510(k) Number K103751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2010
Decision Date March 22, 2011
Days to Decision 89 days
Submission Type Traditional
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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K103751.
ATB ADVANCE PTA DILATATION CATHETER
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CHARGER PTA BALLON DILATATION CATHETER
K112697 · Boston Scientific · Nov 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · Boston Scientific Corporation · May 2011
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
K103464 · Medtronic, Inc. · Dec 2010
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS
K093965 · C.R. Bard, Inc. · Mar 2010
PICA CATHETER
K093970 · Penumbra, Inc. · Jan 2010