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CHIKAI Nexus petit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252011

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K252011 FDA 510(k)
FDA Product Code
MOF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a guide wire for neurovasculature, classified as a Class 2 medical device under FDA regulation 870.1330 with product code MOF. It is substantially equivalent to a predicate device and received traditional 510(k) clearance (K252011) from the FDA.

Manufactured by Asahi Intecc Co., Ltd. in Seto, Japan, the device is supplied as a single unit and is intended for use in cardiovascular and neurovascular procedures. It is not described as sterile, single-use, reusable, or MRI-safe in the provided data, and no storage conditions are specified.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CHIKAI® Nexus 014 | Asahi Intecc Medical, Asahi Chikai - Asahi Intecc Medical Products, K252011 FDA 510(k) - CHIKAI Nexus petit | Asahi Intecc Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (1)

  • FDA 510(k) K252011 24 fields · synced Sep 22, 2026