ASAHI Neurovascular Guide Wire CHIKAI X 014 soft— 510(k) K191714

Name: FDA 510(k) clearance K191714
Creator: U.S. Food and Drug Administration
Published: 2019-07-26

Substantially Equivalent

Asahi Intecc Co., Ltd.

FDA 510(k) clearance K191714 for ASAHI Neurovascular Guide Wire CHIKAI X 014 soft, Substantially Equivalent on 2019-07-26. Applicant: Asahi Intecc Co., Ltd.. Device class: 2.

Clearance details

Applicant: Asahi Intecc Co., Ltd.
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2019-06-26
Decision date: 2019-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Seto, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOF

view all

K260751 — 35 Helix Guidewire2026-08-27
K262424 — Willow 12 Guidewire2026-08-14
K260223 — Aristotle Mini Guidewire2026-08-06
K254006 — Drivewire 35 Guidewire2026-07-17
K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire2026-04-29

More clearances from Asahi Intecc Co., Ltd.

view all

K254178 — SAYA 86 Radial Access Guide Catheter2026-05-11
K252011 — CHIKAI Nexus petit2026-02-02
K251240 — Branchor X Balloon Guide Catheter2025-06-20
K251560 — FUBUKI XF-R Neurovascular Long Sheath2025-06-20
K243383 — CHIKAI Nexus 0142025-04-21

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.