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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 K022738
Device Name AGILTRAC .035 PERIPHERAL DILATATION CATHETER
Applicant
Guidant Corp.
1525 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact NADINE SAKAKINI
Correspondent
Guidant Corp.
1525 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact NADINE SAKAKINI
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/19/2002
Decision Date 09/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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