# K241962: Crossloop

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Mar 27, 2025 after 267 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: 14 generations back to K890505 (1989). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371, Asahi Intecc Co., Ltd. (2007) Summary page 5.
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension, Asahi Intecc Co., Ltd. (2017) 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).

Source page: https://510kreport.com/device/K241962
Methodology: https://510kreport.com/methodology