Cleared Traditional

ComboCath OTW PTA Dilatation Catheter (K150452) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150452 · Summa Therapeutics, LLC · Cardiovascular device
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Aug 2015
Decision
174d
Days
Class 2
Risk

K150452 is an FDA 510(k) clearance for the ComboCath OTW PTA Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Summa Therapeutics, LLC (Mountain View, US). The FDA issued a Cleared decision on August 13, 2015 after a review of 174 days - an extended review 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: 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 Summa Therapeutics, LLC devices

Submission Details

510(k) Number K150452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date August 13, 2015
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
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 168
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K150452.
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K162350 · Boston Scientific Corporation · Nov 2016
XXL Vascular Balloon Dilatation Catheter
K150303 · Boston Scientific Corp · Jun 2015
PTA BALLOON DILATATION CATHETER
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MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
K141521 · Boston Scientific Corporation · Aug 2014