Cleared Traditional

EBONY PTA .035 PERIPHERAL DILATATION CATHETER

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

About This 510(k) Submission

K103354 is an FDA 510(k) clearance for the EBONY PTA .035 PERIPHERAL DILATATION CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Natec Medical , Ltd. (Crofton, US). The FDA issued a Cleared decision on February 23, 2011, 99 days after receiving the submission on November 16, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K103354 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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