# K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Apr 3, 2017 after 118 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: 13 generations back to K890505 (1989). 42 ancestors in all.
11 later devices descend from it; 7 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)
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050, Jomed, Inc. (2002) Summary page 4.
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002, Jomed, Inc. (2003) Summary page 4.
- K032615: Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300, Asahi Intecc Co., Ltd. (2003) Summary page 4.
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 4.
- K043422: Asahi Ptca Guide Wire, J Shape Series, Asahi Intecc Co., Ltd. (2005) Summary page 4.
- K052022: Asahi Ptca Guide Wire Fielder, Asahi Intecc Co., Ltd. (2005) Summary page 4.
- K052339: Asahi Ptca Guide Wire, Asahi Intecc Co., Ltd. (2005) Summary page 4.
- K062186: Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J, Asahi Intecc Co., Ltd. (2006) Summary page 4.
- K063819: Asahi Ptca Guide Wire, Fielder FC, Asahi Intecc Co., Ltd. (2007) Summary page 4.
- K072431: Asahi Ptca Guide Wire, X-Treme, Asahi Intecc Co., Ltd. (2007) Summary page 4.
- K072705: Asahi Ptca Guide Wire, Fielder FC J, Models: AGP140001J, AGP140301J, Asahi Intecc Co., Ltd. (2007) Summary page 4.
- K083904: Asahi Suoh Ptca Guide Wire, Asahi Intecc Co., Ltd. (2009) Summary page 4.
- K100578: Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S, Asahi Intecc Co., Ltd. (2010) Summary page 4.
- K101986: Asahi Ultimatebros 3 Ptca Guide Wire, Asahi Intecc Co., Ltd. (2011) Summary page 4.
- 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 4.
- K122469: Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ, Asahi Intecc Co., Ltd. (2013) Summary page 4.
- K133865: Asahi Gaia First, Second, Third, Asahi Intecc Co., Ltd. (2014) Summary page 4.
- K153106: ASAHI Fielder XT-A, ASAHI Fielder XT-R, Asahi Intecc Co., Ltd. (2016) Summary page 4.
- K061984: Treasure, Asahi Intecc Co., Ltd. (2006) Summary page 4.
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371, Asahi Intecc Co., Ltd. (2007) Summary page 4.
- K083146: Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000, Asahi Intecc Co., Ltd. (2008) Summary page 4.
- K103057: Asahi Astato XS 20 Peripheral Guide Wire, Asahi Intecc Co., Ltd. (2010) Summary page 4.
- K110553: Asahi Treasure Floppy Peripheral Guide Wire, Asahi Intecc USA, Inc. (2011) Summary page 4.
- K150445: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV), Asahi Intecc Co., Ltd. (2015) Summary page 4.
- K153443: ASAHI Astato XS 40, Asahi Intecc Co., Ltd. (2016) Summary page 4.
- K083145: Asahi Guide Wire Extension, Model AG149000, Asahi Intecc Co., Ltd. (2009) Summary page 4.
- K101985: Asahi Guide Wire Extension 165CM, Asahi Intecc Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K203533: Vassallo GT (2021), 3 descendants of its own
- K203529: VASSALLO GT Hybrid (2021), 1 descendant of its own
- K243733: SION blue PLUS (2025), 0 descendants of its own
- K241962: Crossloop (2025), 0 descendants of its own
- K241702: CROSSLEAD 0.014inch (2025), 0 descendants of its own

## Indications for use
ASAHI PTCA Guide Wires: ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature. ASAHI Peripheral Guide Wires: ASAHI Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only. ASAHI Guide Wire Extension: The ASAHI Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.

Source page: https://510kreport.com/device/K163426
Methodology: https://510kreport.com/methodology