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Asahi Neurovascular Guide Wire Chikai X 010

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K183070

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K183070 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 Asahi Neurovascular Guide Wire Chikai X 010 is a neurovascular guide wire designed for use in interventional neuroradiology procedures. It is classified as a guide wire, catheter, and neurovascular device, intended for navigating and supporting catheters within blood vessels of the brain and central nervous system.

This device is supplied sterile and intended for single-use. It is regulated under the FDA 510(k) pathway with a classification of Class II and is authorized under the Medical Device Directive (MDD). The Chikai X 010 is manufactured by Asahi Intecc Co., Ltd., and its specifications are tailored for precise vascular access in neurovascular interventions.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (2)

  • FDA 510(k) K183070 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026