# K970962: JMS AV Fistula Needle

- Pathway: 510(k) (Traditional)
- Applicant: Jms Co., Ltd.
- Decided: Aug 7, 1997 after 143 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 intended to Use for temporary cannulation for vascular access for extracorporeal blood treatment. single use only and is for temporary catheterization less than 30 days.

Source page: https://510kreport.com/device/K970962
Methodology: https://510kreport.com/methodology