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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K032737
Device Name CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA
Applicant
Cordis Europa, N.V.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
Cordis Europa, N.V.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received09/04/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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