# K242597: CROSSLEAD 0.018inch

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Mar 5, 2025 after 187 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: 12 generations back to K890505 (1989). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213868: ASAHI Gladius Mongo18 PV ES, Asahi Intecc Co., Ltd. (2022) Summary page 5.

## Indications for use
This product is intended to direct a catheter to the desired anatomical location in the peripheral vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K242597
Methodology: https://510kreport.com/methodology