FDA 510(k) Application Details - K122878

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K122878
Device Name	Catheter, Ultrasound, Intravascular
Applicant	SILICON VALLY MEDICAL INSTRUMENTS, INC. 47697 WESTINGHOUSE SUITE 101 FREMONT, CA 94539 US Other 510(k) Applications for this Company
Contact	RICHARD E ANDERSON 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	09/19/2012
Decision Date	01/11/2013
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