Cleared Special

K120677 - CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)

K120677 is an FDA 510(k) clearance for CHOCOLATE PTA BALLON CATHETER (OVER THE..., 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 9-day FDA review.

K120677 · Trireme Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
9d
Days
Class 2
Risk

K120677 is an FDA 510(k) clearance for the CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014). 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 March 15, 2012 after a review of 9 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.

FDA 510(k) Submission Details - K120677

510(k) Number K120677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2012
Decision Date March 15, 2012
Days to Decision 9 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Intertek Testing Services
WILLIAM SAMMONS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 381
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