# K032615: Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Sep 16, 2003 after 22 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: 5 generations back to K890505 (1989). 8 ancestors in all.
52 later devices descend from it; 5 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050, Jomed, Inc. (2002)
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002, Jomed, Inc. (2003)

## Most influential descendants
- K043422: Asahi Ptca Guide Wire, J Shape Series (2005), 50 descendants of its own
- K062186: Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J (2006), 49 descendants of its own
- K070945: Asahi Ptca Guide Wire (2008), 48 descendants of its own
- K100578: Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S (2010), 36 descendants of its own
- K122469: Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ (2013), 31 descendants of its own

## Indications for use
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 vessel.

Source page: https://510kreport.com/device/K032615
Methodology: https://510kreport.com/methodology