# K191464: Asahi PTCA Guide Wire Asahi SION Series

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Nov 21, 2019 after 171 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: 11 generations back to K890505 (1989). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100578: Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S, Asahi Intecc Co., Ltd. (2010) Summary page 4.
- K122468: Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM Asahi Ptca Guide Wire Asahi Sio, Asahi Intecc Co., Ltd. (2013) Summary page 4.
- K122469: Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ, Asahi Intecc Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K243733: SION blue PLUS (2025), 0 descendants of its own

## Indications for use
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

Source page: https://510kreport.com/device/K191464
Methodology: https://510kreport.com/methodology