FDA 510(k) Application Details - K131060

Device Classification Name	More FDA Info for this Device
510(K) Number	K131060
Device Name	CLEARGUARD HD END CAP
Applicant	PURSUIT VASCULAR, INC 6901 E. FISH LAKE ROAD SUITE 166 MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	LAURIE E LYNCH, PH.D. Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2013
Decision Date	12/16/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review