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Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connec…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K140536

by Lake Region Medical

Identifiers

510(k) Number
K140536 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)

This device is a guidewire designed for cardiovascular applications, classified under product code DQX. It is engineered to provide high torque transmission, facilitating precise navigation within coronary and peripheral vascular systems. The series includes standard, flexible, and high-torque variants to accommodate varying clinical needs, such as complex anatomy or tortuous vessels.

The guidewires are supplied sterile and intended for single-use, as indicated by their regulatory submissions (FDA 510K clearance and MDR compliance). They are manufactured by Lake Region Medical and distributed globally, with no specific MRI safety restrictions noted. Storage requires adherence to sterile packaging integrity until use. Authorisations include a traditional 510(k) clearance under the Cardiovascular Advisory Committee, with no third-party review involved.

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

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lake Region Medical

Sources (2)

  • FDA 510(k) K140536 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026