# K063819: Asahi Ptca Guide Wire, Fielder FC

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jan 26, 2007 after 31 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: 6 generations back to K890505 (1989). 9 ancestors in all.
51 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)
- K052022: Asahi Ptca Guide Wire Fielder, Asahi Intecc Co., Ltd. (2005) Summary page 1.
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050, Jomed, Inc. (2002) Summary page 1.
- K974773: HI-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Standard Guide Wire with Hydrocoat Hydrophilic, Guidant Corp. (1998) Summary page 1.
- K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating., Guidant Corp. (1999) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The ASAHI PTCA Guide Wire, Fielder FC is 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/K063819
Methodology: https://510kreport.com/methodology