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Asahi Guide Wire Extension 165CM

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K101985

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K101985 FDA 510(k)
FDA Product Code
DQX 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 Guide Wire Extension 165cm is a guidewire extension device designed to elongate existing guidewires for enhanced reach during interventional procedures. It is classified as a guidewire extension, intended to facilitate catheter navigation and device exchange in complex vascular access scenarios.

This device is supplied as a single-use, non-sterile item and is intended for use in cardiovascular settings. The 165cm length is specified for compatibility with non-300cm ASAHI guidewires, and it adheres to FDA 510(k) clearance (K101985) and MDD regulatory standards. Storage and handling should follow manufacturer guidelines to maintain device integrity.

Frequently asked questions

Is this guide wire extension meant for use with all types of guidewires, or is it specifically designed for compatibility with certain ones?

This extension is specifically designed for compatibility with non-300cm Asahi guidewires. The 165cm length is tailored to elongate these shorter guidewires, improving reach during procedures without requiring a full 300cm guidewire.

How should I store the Asahi Guide Wire Extension 165cm to ensure it remains in good condition for use?

The device should be stored following the manufacturer’s guidelines to preserve its integrity. While it is non-sterile and single-use, proper storage conditions—such as protection from moisture, extreme temperatures, and physical damage—will help maintain its functionality until use.

Can this guide wire extension be reused after a single procedure, or is it intended for one-time use only?

The Asahi Guide Wire Extension 165cm is explicitly labeled as a single-use device. Reuse is not recommended, as it could compromise sterility, structural integrity, or performance during subsequent procedures.

What type of interventional procedures is this extension typically used for, and why is the 165cm length beneficial?

This extension is intended for cardiovascular settings where enhanced guidewire reach is needed, such as complex catheter navigation or device exchange in challenging vascular access scenarios. The 165cm length bridges the gap between shorter guidewires and the limitations of standard catheter lengths, improving maneuverability without requiring a full 300cm guidewire.

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: ASAHI EXTENSION® 165 | Asahi Intecc Medical, Extension - ASAHI INTECC MEDICAL PRODUCTS, ASAHI Extension Wire - VPMED Group, ASAHI Extension | Coronary製品情報 | ASAHI INTECC PRODUCTS, K101985 - ASAHI GUIDE WIRE EXTENSION 165CM | FDA 510 (k)

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) K101985 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026