Cleared Special

K143041 - Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

K143041 is an FDA 510(k) clearance for Ebony PTA 0.014'' over the wire Cathete..., manufactured by Natec Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 225-day FDA review.

K143041 · Natec Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
225d
Days
Class 2
Risk

K143041 is an FDA 510(k) clearance for the Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Ca.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Natec Medical , Ltd. (Reduit, MU). The FDA issued a Cleared decision on June 4, 2015 after a review of 225 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natec Medical , Ltd. devices

FDA 510(k) Submission Details - K143041

510(k) Number K143041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2014
Decision Date June 04, 2015
Days to Decision 225 days
Submission Type Special
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
100d slower than avg
Panel avg: 125d · This submission: 225d
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 Consultant

CardioMed Device Consultants, LLC
Xavier de Buchere

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 368
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