FDA 510(k) Application Details - K070979

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K070979
Device Name	Catheter, Continuous Flush
Applicant	ICU MEDICAL, INC 4455 ATHERTON DR. SALT LAKE CITY, UT 84123 US Other 510(k) Applications for this Company
Contact	TRACY BEST Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2007
Decision Date	09/19/2007
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