# K213315: CROSSLEAD Peripheral Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jul 1, 2022 after 270 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: 2 generations back to K863138 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063372: Radifocus Glidewire Advantage, Terumo Medical Corp. (2007) Summary page 4.

## Most influential descendants
- K261281: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 (2026), 0 descendants of its own

## 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/K213315
Methodology: https://510kreport.com/methodology