# K183062: ASAHI Silverway

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jul 1, 2019 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: 1 generation back to K935170 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935170: Cardiovascular and Vascular Guidewire Modifications, Lake Region Mfg., Inc. (1994) Summary page 4.

## Indications for use
This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

Source page: https://510kreport.com/device/K183062
Methodology: https://510kreport.com/methodology