Cleared Special

POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

K121442 · Cordis Corporation · Cardiovascular
Jun 2012
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K121442 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 Corporation (Bridgewater, US). The FDA issued a Cleared decision on June 14, 2012, 30 days after receiving the submission on May 15, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K121442 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2012
Decision Date June 14, 2012
Days to Decision 30 days
Submission Type Special
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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