# K993187: Shelly Protected AV Fistula Needle

- Pathway: 510(k) (Traditional)
- Applicant: Diasol, Inc.
- Decided: Nov 5, 1999 after 43 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Shelly Protected Fistula Needle is part of the hemodialysis system that connects patients to the machine and provides access to patient's blood. It is also used in plasmapheresis for the same purpose. Shelly Protected Fistula Needle has a shield that when activated enclose the needle. This mechanism is intended to reduce the incidence of accidental needlesticks.

Source page: https://510kreport.com/device/K993187
Methodology: https://510kreport.com/methodology