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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 POWDER HORN DR.
WARREN,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
CORDIS EUROPA N.V.
7 POWDER HORN 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
Recalls CDRH Recalls
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