# K261281: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035

- Pathway: 510(k) (Traditional)
- Applicant: Filmecc Co., Ltd.
- Decided: Sep 3, 2026 after 139 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: 3 generations back to K863138 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213315: CROSSLEAD Peripheral Guide Wire, Asahi Intecc Co., Ltd. (2022) Summary page 5.
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986) Summary page 5.
- K152740: Radifocus Glidewire, Ashitaka Factory of Terumo Corp. (2015) Summary page 5.

## 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. This device is intended for peripheral vascular use only.

Source page: https://510kreport.com/device/K261281
Methodology: https://510kreport.com/methodology