FDA 510(k) Application Details - K090276

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K090276
Device Name	Catheter, Intravascular, Diagnostic
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	SHELLY PEARCE 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	02/04/2009
Decision Date	02/19/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review