FDA 510(k) Application Details - K153485

Device Classification Name	Temporary Carotid Catheter For Embolic Capture   More FDA Info for this Device
510(K) Number	K153485
Device Name	Temporary Carotid Catheter For Embolic Capture
Applicant	SILK ROAD MEDICAL, INC. 735 NORTH PASTORIA AVENUE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	KRISTIN ELLIS Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2015
Decision Date	03/10/2016
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