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510(k) Data Aggregation
K Number
K130873Device Name
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
Manufacturer
Date Cleared
2013-09-13
(168 days)
Product Code
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
VITAL ACCESS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VWING Vascular Needle Guide is indicated for use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.
Device Description
The VWING vascular needle guide has been designed to facilitate repeated needle access to the vasculature. The VWING vascular needle guide is an accessory for constant site or "buttonhole" method of needle insertion and is indicated for use for patient therapies requiring repeated access to the vascular system. such as hemodialysis. It is a single piece of titanium device that is implanted subcutaneously and attached to the outside of the vasculature, including on arteriovenous fistulae (AVF). The VWING acts as a guide for needles and accommodates currently available 15-17 gage needles to accurately cannulate the targeted vessel.
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