# K100578: Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Sep 22, 2010 after 205 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: 9 generations back to K890505 (1989). 17 ancestors in all.
36 later devices descend from it; 5 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083904: Asahi Suoh Ptca Guide Wire, Asahi Intecc Co., Ltd. (2009) Summary page 1.
- K070945: Asahi Ptca Guide Wire, Asahi Intecc Co., Ltd. (2008) 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
- K122469: Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ (2013), 31 descendants of its own
- K133865: Asahi Gaia First, Second, Third (2014), 29 descendants of its own
- K153106: ASAHI Fielder XT-A, ASAHI Fielder XT-R (2016), 21 descendants of its own
- K122468: Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM Asahi Ptca Guide Wire Asahi Sio (2013), 16 descendants of its own
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (2017), 11 descendants of its own

## Indications for use
The ASAHI SIGN PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI SIGN PTCA Guide Wire is not to be used in the cerebral blood vessel.

Source page: https://510kreport.com/device/K100578
Methodology: https://510kreport.com/methodology