# K211898: ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Dec 8, 2021 after 170 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: 14 generations back to K890505 (1989). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171933: ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter, Asahi Intecc Co., Ltd. (2018) Summary page 4.

## Indications for use
PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The PCI Guide Wires are not to be used in the neurovasculature.

Source page: https://510kreport.com/device/K211898
Methodology: https://510kreport.com/methodology