Cleared Traditional

EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER

K112513 · Natec Medical , Ltd. · Cardiovascular
Dec 2011
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K112513 is an FDA 510(k) clearance for the EBONY PTA 0.014 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 December 9, 2011, 101 days after receiving the submission on August 30, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K112513 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2011
Decision Date December 09, 2011
Days to Decision 101 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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