FDA 510(k) Application Details - K130873

Device Classification Name	More FDA Info for this Device
510(K) Number	K130873
Device Name	VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
Applicant	VITAL ACCESS 2302 S.PRESIDENTS DR SUITE C SALT LAKE CITY, UT 84120 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER PHILLIPS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2013
Decision Date	09/13/2013
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