# K230377: CROSSLEAD Penetration Peripheral Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jul 20, 2023 after 157 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: 11 generations back to K890505 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153443: ASAHI Astato XS 40, Asahi Intecc Co., Ltd. (2016) Summary page 4.

## Indications for use
This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K230377
Methodology: https://510kreport.com/methodology