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Crosslead 0.018inch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242597

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K242597 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 Crosslead 0.018inch is a peripheral guide wire designed to facilitate cap engagement and navigation of complex lesions. It features a nitinol core and is engineered to provide a balance between torque response and shaft support.

This device is supplied with a hydrophilic coating and an uncoated tip for radiopacity. It is authorized under FDA 510k clearance, identified by K-number K242597.

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: CROSSLEAD Penetration® 0.018″ | Asahi Intecc Medical, CROSSLEAD 0.018 | Peripheral製品情報 | ASAHI INTECC PRODUCTS, PDF CROSSLEAD Pro 014/018 - asahi-inteccusa-medical.com, CROSSLEAD® Pro 018 | Asahi Intecc Medical

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) K242597 24 fields · synced Sep 23, 2026