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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 K021284
Device Name EASYTRAK GUIDING CATHETER
Applicant
GUIDANT CORP.
4100 HAMLINE AVE., NORTH
ST. PAUL,  MN  55112 -5798
Applicant Contact KAREN S ALSOP
Correspondent
GUIDANT CORP.
4100 HAMLINE AVE., NORTH
ST. PAUL,  MN  55112 -5798
Correspondent Contact KAREN S ALSOP
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/18/2002
Decision Date 05/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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