Cleared Traditional

K150452 - ComboCath OTW PTA Dilatation Catheter

K150452 is an FDA 510(k) clearance for ComboCath OTW PTA Dilatation Catheter, manufactured by Summa Therapeutics, LLC. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 174-day FDA review.

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

FDA 510(k) Submission Details - K150452

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.

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 265
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K150452.
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