FDA 510(k) Application Details - K112050

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K112050
Device Name	Catheter, Ultrasound, Intravascular
Applicant	BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD DIAMOND BAR, CA 91765 US Other 510(k) Applications for this Company
Contact	MARINA GUEVREKIAN Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2011
Decision Date	11/18/2011
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