# K041740: Silicone Coated Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Oct 15, 2004 after 109 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: 1 generation back to K905581 (1991). 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)
- K905581: Silicone Coated Guidewires, Lake Region Mfg., Inc. (1991) Summary page 1.

## Indications for use
To facilitate the placement of devices used during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K041740
Methodology: https://510kreport.com/methodology