# K133865: Asahi Gaia First, Second, Third

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Mar 18, 2014 after 89 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: 11 generations back to K890505 (1989). 20 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101986: Asahi Ultimatebros 3 Ptca Guide Wire, Asahi Intecc Co., Ltd. (2011) Summary page 1.
- K100578: Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S, Asahi Intecc Co., Ltd. (2010) Summary page 1.
- K122469: Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ, Asahi Intecc Co., Ltd. (2013) 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.

## Most influential descendants
- K153106: ASAHI Fielder XT-A, ASAHI Fielder XT-R (2016), 21 descendants of its own
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (2017), 11 descendants of its own
- K171933: ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter (2018), 7 descendants of its own
- K141339: Asahi RG3 Guidewire/Asahi RG3 Soft Guidewire (2014), 6 descendants of its own
- K151234: R350 guidewire (2015), 5 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 neurovasculature.

Source page: https://510kreport.com/device/K133865
Methodology: https://510kreport.com/methodology