# K241784: Arrow® Nitinol Wire

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Sep 18, 2024 after 90 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K770977 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142393: Predicate Iii Guidewire, Lake Region Medical (2014) Summary page 5.

## Indications for use
The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K241784
Methodology: https://510kreport.com/methodology