Cleared Traditional

K150303 - XXL Vascular Balloon Dilatation Catheter

K150303 is an FDA 510(k) clearance for XXL Vascular Balloon Dilatation Catheter, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K150303 · Boston Scientific Corp · Cardiovascular device
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Jun 2015
Decision
129d
Days
Class 2
Risk

K150303 is an FDA 510(k) clearance for the XXL Vascular Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on June 15, 2015 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K150303

510(k) Number K150303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2015
Decision Date June 15, 2015
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

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 344
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K150303.
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
K143193 · Boston Scientific · Jul 2015
Armada 18 PTA Catheter
K151317 · Abbott Vascular · Jul 2015
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
K143093 · Hotspur Technologies, Inc., · Jun 2015
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
K143041 · Natec Medical , Ltd. · Jun 2015
PTA 14 Balloon Dilatation Catheter OTW
K142954 · Texasmedical Technologies, Inc. · May 2015
ELM PTA Balloon Dilatation Catheter
K143561 · O'Connell Regulatory Consultants, Inc. · May 2015