# K013384: Sharghp a.V. Fistula Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Shargh Pharmaceutical Co., Inc.
- Decided: Jan 7, 2002 after 87 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
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
This device is an A.V. Fistula Needle Set part of extracorporial artificial kidney system for the treatment of patients with renal failure in order to access to the patient’s blood vessel for Hemodialysis.

Source page: https://510kreport.com/device/K013384
Methodology: https://510kreport.com/methodology