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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 K013638
Device Name MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
Applicant
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA,  CA  92591 -4630
Applicant Contact NANCY E RALSTON
Correspondent
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA,  CA  92591 -4630
Correspondent Contact NANCY E RALSTON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/05/2001
Decision Date 12/04/2001
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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