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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 K012002
Device Name VIKING OPTIMA GUIDING CATHETER
Applicant
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA,  CA  92591 -4630
Applicant Contact STACEY SIMON
Correspondent
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA,  CA  92591 -4630
Correspondent Contact STACEY SIMON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/27/2001
Decision Date 07/26/2001
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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