Cleared Traditional

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter

K160256 · Brosmed Medical Co., Ltd. · Cardiovascular
Jul 2016
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K160256 is an FDA 510(k) clearance for the Polux , Minerva and Atropos PTA Balloon Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Brosmed Medical Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on July 29, 2016, 179 days after receiving the submission on February 1, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K160256 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2016
Decision Date July 29, 2016
Days to Decision 179 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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