# K130873: Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X 07MM; Vwing Vascular Needle Guide, 8MM X 07M

- Pathway: 510(k) (Traditional)
- Applicant: Vital Access
- Decided: Sep 13, 2013 after 168 days
- Product code: PFH (Venous Window Needle Guide)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K823068 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990803: Medisystems Buttonhole Needle Sets, Medisystems Corp. (2000) Summary page 1.
- K926139: Cathlink 20 Titanium Port W/Att. Polyurethane Cath, Bard Access Systems, Inc. (1995) Summary page 1.

## Indications for 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.

Source page: https://510kreport.com/device/K130873
Methodology: https://510kreport.com/methodology