FDA 510(k) Application Details - K003020

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K003020
Device Name	Catheter, Intravascular, Diagnostic
Applicant	CD LEYCOM BV ARGONSTRAAT 116 ZOETERMEER 2718 SP NL Other 510(k) Applications for this Company
Contact	TIM LENIHAN 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	09/27/2000
Decision Date	05/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review