# K150445: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jun 30, 2015 after 130 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: 10 generations back to K890505 (1989). 28 ancestors in all.
16 later devices descend from it; 6 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)
- K083146: Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000, Asahi Intecc Co., Ltd. (2008) Summary page 4.
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371, Asahi Intecc Co., Ltd. (2007) Summary page 4.
- K103057: Asahi Astato XS 20 Peripheral Guide Wire, Asahi Intecc Co., Ltd. (2010) Summary page 4.

## Most influential descendants
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (2017), 11 descendants of its own
- K203533: Vassallo GT (2021), 3 descendants of its own
- K213868: ASAHI Gladius Mongo18 PV ES (2022), 1 descendant of its own
- K212268: FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT (2022), 1 descendant of its own
- K203529: VASSALLO GT Hybrid (2021), 1 descendant of its own

## Indications for use
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Source page: https://510kreport.com/device/K150445
Methodology: https://510kreport.com/methodology