# K182844: Asahi Sasuke

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jun 22, 2019 after 256 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K060327 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter, Vascular Solutions, Inc. (2006) Summary page 4.

## Indications for use
This product is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary arterial vasculature and peripheral vessels, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures, and to subselectively infuse/deliver diagnostic or therapeutic agents. Not for use in the neurovasculature.

Source page: https://510kreport.com/device/K182844
Methodology: https://510kreport.com/methodology