FDA 510(k) Application Details - K123267

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K123267
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	KOFU FACTORY OF TERUMO CORP. 950 ELKTON BLVD ELKTON, MD 21921 US 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	10/19/2012
Decision Date	11/02/2012
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