# K122468: Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM Asahi Ptca Guide Wire Asahi Sio

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Mar 8, 2013 after 207 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). 18 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 35 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 1.
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050, Jomed, Inc. (2002) Summary page 1.

## 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
- K191464: Asahi PTCA Guide Wire Asahi SION Series (2019), 1 descendant of its own
- K190176: Minamo (2019), 1 descendant 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 cerebral blood vessels.

Source page: https://510kreport.com/device/K122468
Methodology: https://510kreport.com/methodology