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Asahi Neurovascular Guide Wire: Asahi Chikai Black 14 Soft Tip

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161912

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K161912 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: Asahi Chikai Black 14 Soft Tip is a neurovascular guide wire designed for use in cerebrovascular procedures. It is classified as a guide wire, catheter, and neurovascular device, intended for navigating and positioning within blood vessels of the brain and neck.

This device is supplied sterile and intended for single-use. It is classified under FDA device class II and regulated under the Medical Office Facility (MOF) product code. The Asahi Chikai Black 14 Soft Tip features a soft tip for enhanced maneuverability and safety during neurovascular interventions, with regulatory authorisations including FDA 510(k) clearance and compliance with the Medical Device Directive (MDD).

Frequently asked questions

What is the primary purpose of the ASAHI CHIKAI black 14 soft tip neurovascular guide wire in clinical practice?

The ASAHI CHIKAI black 14 soft tip neurovascular guide wire is specifically designed for navigating and positioning within blood vessels of the brain and neck during cerebrovascular procedures. Its soft tip enhances maneuverability and safety, making it suitable for delicate interventions in neurovascular applications.

Is this device intended for reuse or is it single-use only?

This device is explicitly intended for single-use only, as stated in the product description. It is supplied sterile to ensure safety and efficacy for one-time clinical use.

What regulatory pathways has this device undergone, and what does that mean for its use?

The ASAHI CHIKAI black 14 soft tip has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD). The FDA classification for this device is Class II, indicating it has undergone a premarket review to ensure its safety and effectiveness for its intended use in cerebrovascular procedures.

How is this guide wire packaged and stored for clinical use?

The device is supplied sterile, which means it is pre-packaged and ready for immediate clinical use without additional sterilization. Proper storage should follow manufacturer guidelines to maintain sterility and functionality until use.

What should clinicians consider when selecting this guide wire for a procedure?

Clinicians should consider the soft tip design of the ASAHI CHIKAI black 14, which provides enhanced maneuverability and safety in navigating delicate neurovascular pathways. Its single-use nature ensures sterility and reduces the risk of cross-contamination, while its FDA clearance and compliance with MDD standards support its reliability for cerebrovascular 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) K161912 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026