Cleared Traditional

K103354 - EBONY PTA .035 PERIPHERAL DILATATION CA...

K103354 is an FDA 510(k) clearance for EBONY PTA .035 PERIPHERAL DILATATION CA..., manufactured by Natec Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K103354 · Natec Medical , Ltd. · Cardiovascular device
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Feb 2011
Decision
99d
Days
Class 2
Risk

K103354 is an FDA 510(k) clearance for the EBONY PTA .035 PERIPHERAL DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Natec Medical , Ltd. (Crofton, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 99 days - within the typical 510(k) review window.

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 Natec Medical , Ltd. devices

FDA 510(k) Submission Details - K103354

510(k) Number K103354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2010
Decision Date February 23, 2011
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 264
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K103354.
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · Boston Scientific Corporation · May 2011
EVERCROSS 0.035 OTW PTA DILATATION CATHETER
K110319 · Ev3, Inc. · Apr 2011
MUSTANG BALLOON DILATATION CATHETERS
K103751 · Boston Scientific · Mar 2011
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K103464 · Medtronic, Inc. · Dec 2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
K103322 · Ev3, Inc. · Dec 2010
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS
K093965 · C.R. Bard, Inc. · Mar 2010