FDA 510(k) Application Details - K031599

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K031599
Device Name	Catheter, Intravascular, Diagnostic
Applicant	CD LEYCOM BV ARGONSTRAAT 116 ZOETERMEER 2718 SP NL Other 510(k) Applications for this Company
Contact	T. LOPES Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2003
Decision Date	12/09/2003
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