FDA 510(k) Application Details - K052865

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K052865
Device Name	Catheter, Intravascular, Diagnostic
Applicant	ICU MEDICAL, INC. 275 North Field Drive Lake Forest, IL 60045 US Other 510(k) Applications for this Company
Contact	TOM KOZMA 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	10/11/2005
Decision Date	12/22/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review