510(k) K130873

Device
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
Applicant
VITAL ACCESS
510(k) number
K130873
Product code
PFH  
Decision
Substantially Equivalent (SESE)
Decision date
2013-09-13
Date received
2013-03-29
Regulation
876.5540
Classification name
Venous Window Needle Guide
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHRISTOPHER PHILLIPS
Address
2302 S.Presidents Dr. Suite C Salt Lake City UT US 84120 84120

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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