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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name venous window needle guide
510(k) Number K130873
Models 00144, 00145, 00146, 00153
Device Name VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
Original Applicant
VITAL ACCESS
2302 s.presidents dr
suite c
salt lake city,  UT  84120
Original Contact christopher phillips
Regulation Number876.5540
Classification Product Code
PFH  
Date Received03/29/2013
Decision Date 09/13/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Clinical Trials NCT01471041
Reviewed by Third Party No
Expedited Review No
Combination Product No
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