FDA 510(k) Application Details - K091780

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K091780
Device Name	Catheter, Intravascular, Diagnostic
Applicant	MEDIGUIDE, LTD. 555 THIRTEENTH ST NW COLUMBIA SQUARE WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2009
Decision Date	10/16/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review