FDA 510(k) Application Details - K033650

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K033650
Device Name	Catheter, Ultrasound, Intravascular
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY MOUNTAIN VIEW, CA 94039-7393 US Other 510(k) Applications for this Company
Contact	ISKRA MRAKOVIC 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	11/20/2003
Decision Date	02/24/2004
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	N
Expedited Review