# K241158: ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Jun 25, 2024 after 60 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: 3 generations back to K960806 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013789: Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189, Boston Scientific, Target (2001) Summary page 4.

## Indications for use
This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide catheter and guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.

Source page: https://510kreport.com/device/K241158
Methodology: https://510kreport.com/methodology