# K991623: Nipro Arterial Venous Fistula Needle, Agulha Para Fistula Arterio-Venosa, Aguja Para Fistula Arterio Venosa

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Aug 9, 1999 after 90 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 K955182 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955182: Nipro Arterial Venous Fistula Needle, Nissho Corp. (1996) Summary page 1.

## Indications for use
The AVF sets are intended to be used for intravenous injection and connection with dialysis blood lines to transport blood from the artery of the patient to the dialyzer and transport after dialysis to the vein of the patient.

Source page: https://510kreport.com/device/K991623
Methodology: https://510kreport.com/methodology