Cleared Special

K122070 - CHOCOLATE PTA BALLOON CATHETER (OVER TH...

K122070 is an FDA 510(k) clearance for CHOCOLATE PTA BALLOON CATHETER (OVER TH..., manufactured by Trireme Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 30-day FDA review.

K122070 · Trireme Medical, Inc. · Cardiovascular device
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Aug 2012
Decision
30d
Days
Class 2
Risk

K122070 is an FDA 510(k) clearance for the CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PT.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Trireme Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on August 15, 2012 after a review of 30 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 Trireme Medical, Inc. devices

FDA 510(k) Submission Details - K122070

510(k) Number K122070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date August 15, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 278
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K122070.
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