FDA 510(k) Application Details - K003245

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K003245
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. ROUND LAKE, IL 60073 US Other 510(k) Applications for this Company
Contact	LINDA COLEMAN Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2000
Decision Date	12/04/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review