FDA 510(k) Application Details - K031398

Device Classification Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K031398
Device Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant	GUIDANT CORP. 4100 Hamline Avenue North St. Paul, MN 55112-5798 US Other 510(k) Applications for this Company
Contact	Colleen McCarter Bloom Other 510(k) Applications for this Contact
Regulation Number	870.4290   More FDA Info for this Regulation Number
Classification Product Code	DTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2003
Decision Date	05/20/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review