FDA 510(k) Application Details - K122544

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K122544
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	TERUMO Corporation 1727-1, TSUIJIARAI, SHOWA-CHO NAKAKOMA-GUN YAMANASHI 409-3853 JP Other 510(k) Applications for this Company
Contact	SANDI HARTKA 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	08/21/2012
Decision Date	09/05/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review