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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 K020161
Device Name AGILTRAC .018 PERIPHERAL DILATATION CATHETER
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact CURTIS TRUESDALE
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact CURTIS TRUESDALE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/17/2002
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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