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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K991102
Device Name COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
Applicant
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact STACEY SIMON
Correspondent
Guidant Corp.
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact STACEY SIMON
Regulation Number870.4290
Classification Product Code
DTL  
Date Received04/01/1999
Decision Date 06/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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