FDA 510(k) Application Details - K122585

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K122585
Device Name	Filter, Intravascular, Cardiovascular
Applicant	CRUX BIOMEDICAL 1455 ADAMS DRIVE, #1170 MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	ELISA HEBB Other 510(k) Applications for this Contact
Regulation Number	870.3375   More FDA Info for this Regulation Number
Classification Product Code	DTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2012
Decision Date	01/17/2013
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