# K062953: Medisystems Arterial-Venous Fistula Needle Set with Securement Device

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Feb 12, 2007 after 136 days
- Product code: FIE (Needle, Fistula)
- 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: 1 generation back to K941850 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941850: Immobile Non-Sterile and Immobile a/C Non-Sterile, Tnt Moborg Intl., Ltd. (1994) Summary page 3.
- K941940: Immobile Sterile and Immobile a/C Sterile, Tnt Moborg Intl., Ltd. (1994) Summary page 3.

## Indications for use
The Medisystems Hemodialysis Fistula Needle Securement Device, SiteGuard, is intended for use to secure the fistula needle to the patient's skin. The SiteGuard needle securement device has the following features: a. It allows the needle to be held at a consistent angle during treatment; b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and, c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.

Source page: https://510kreport.com/device/K062953
Methodology: https://510kreport.com/methodology