Cleared Special

CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA

K032737 · Cordis Europa, N.V. · Cardiovascular
Oct 2003
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K032737 is an FDA 510(k) clearance for the CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cordis Europa, N.V. (Warren, US). The FDA issued a Cleared decision on October 2, 2003, 28 days after receiving the submission on September 4, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K032737 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2003
Decision Date October 02, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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