# K070945: Asahi Ptca Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jan 9, 2008 after 280 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: 8 generations back to K890505 (1989). 15 ancestors in all.
48 later devices descend from it; 4 cite it directly.
0 of 64 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) Summary page 1.
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002, Jomed, Inc. (2003) Summary page 1.
- K032615: Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300, Asahi Intecc Co., Ltd. (2003) Summary page 1.
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 1.
- K043422: Asahi Ptca Guide Wire, J Shape Series, Asahi Intecc Co., Ltd. (2005) Summary page 1.
- K052022: Asahi Ptca Guide Wire Fielder, Asahi Intecc Co., Ltd. (2005) Summary page 1.
- K052339: Asahi Ptca Guide Wire, Asahi Intecc Co., Ltd. (2005) Summary page 1.
- K062186: Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J, Asahi Intecc Co., Ltd. (2006) Summary page 1.
- K063819: Asahi Ptca Guide Wire, Fielder FC, Asahi Intecc Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- 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
- K101986: Asahi Ultimatebros 3 Ptca Guide Wire (2011), 30 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

## 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 vessel.

Source page: https://510kreport.com/device/K070945
Methodology: https://510kreport.com/methodology