Cleared Traditional

POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

K112797 · Cordis Corp. · Cardiovascular
May 2012
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K112797 is an FDA 510(k) clearance for the POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Cordis Corp. (Bridgewater, US). The FDA issued a Cleared decision on May 4, 2012, 221 days after receiving the submission on September 26, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K112797 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2011
Decision Date May 04, 2012
Days to Decision 221 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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