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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 K031688
Device Name RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
Applicant
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL,  MN  55112 -5798
Applicant Contact STEPHANIE ISGRIGG ROBINSON
Correspondent
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL,  MN  55112 -5798
Correspondent Contact STEPHANIE ISGRIGG ROBINSON
Regulation Number870.4290
Classification Product Code
DTL  
Date Received06/02/2003
Decision Date 07/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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