# K153443: ASAHI Astato XS 40

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Feb 25, 2016 after 90 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: 10 generations back to K890505 (1989). 27 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103057: Asahi Astato XS 20 Peripheral Guide Wire, Asahi Intecc Co., Ltd. (2010) Summary page 4.
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371, Asahi Intecc Co., Ltd. (2007) Summary page 4.

## Most influential descendants
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (2017), 11 descendants of its own
- K203533: Vassallo GT (2021), 3 descendants of its own
- K203529: VASSALLO GT Hybrid (2021), 1 descendant of its own
- K243733: SION blue PLUS (2025), 0 descendants of its own
- K241962: Crossloop (2025), 0 descendants of its own

## Indications for use
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Source page: https://510kreport.com/device/K153443
Methodology: https://510kreport.com/methodology