# K153106: ASAHI Fielder XT-A, ASAHI Fielder XT-R

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jun 21, 2016 after 238 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: 12 generations back to K890505 (1989). 23 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133865: Asahi Gaia First, Second, Third, Asahi Intecc Co., Ltd. (2014) Summary page 4.
- K063819: Asahi Ptca Guide Wire, Fielder FC, 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.
- K072431: Asahi Ptca Guide Wire, X-Treme, Asahi Intecc Co., Ltd. (2007) Summary page 4.

## Most influential descendants
- 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
- K203533: Vassallo GT (2021), 3 descendants of its own
- K212211: Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter (2022), 1 descendant of its own
- K203529: VASSALLO GT Hybrid (2021), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K153106
Methodology: https://510kreport.com/methodology