# K243733: SION blue PLUS

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Apr 2, 2025 after 119 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). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 5.
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension, Asahi Intecc Co., Ltd. (2017) Summary page 5.
- K191464: Asahi PTCA Guide Wire Asahi SION Series, Asahi Intecc Co., Ltd. (2019) Summary page 5.

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

Source page: https://510kreport.com/device/K243733
Methodology: https://510kreport.com/methodology