Cleared Traditional

FILAO NC RX PTCA DILATATION CATHETER

K141933 · Natec Medical , Ltd. · Cardiovascular
Jun 2015
Decision
347d
Days
Class 2
Risk

About This 510(k) Submission

K141933 is an FDA 510(k) clearance for the FILAO NC RX PTCA DILATATION CATHETER, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Natec Medical , Ltd. (Baltimore, US). The FDA issued a Cleared decision on June 28, 2015, 347 days after receiving the submission on July 16, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number K141933 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2014
Decision Date June 28, 2015
Days to Decision 347 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.

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