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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K041574
Device Name CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
Applicant
Guidant Corporation
4100 Hamline Ave. N
St Paul,  MN  55112
Applicant Contact AMITA SHENAI
Correspondent
Guidant Corporation
4100 Hamline Ave. N
St Paul,  MN  55112
Correspondent Contact AMITA SHENAI
Regulation Number870.3620
Classification Product Code
DTD  
Date Received06/14/2004
Decision Date 07/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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