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Pre-Formed Extra Support Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211741

by Lake Region Medical

Identifiers

510(k) Number
K211741 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 Pre-Formed Extra Support Guidewire is a cardiovascular guidewire device classified under product code DQX and regulation 870.1330 as a Wire, Guide, Catheter. It is designed for use in cardiovascular procedures to provide additional support during catheter navigation.

The device was cleared by the FDA through the Traditional 510(k) pathway under K211741, with a decision of Substantially Equivalent (SESE) on November 22, 2021, following a 168-day review. It is manufactured by Lake Region Medical and supplied as a non-sterile, single-use device intended for use in clinical cardiovascular settings.

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: FDA 510 (k) Applications Submitted by Lake Region Medical, K211741 FDA 510 (k) - Pre-Formed Extra Support Guidewire, Pre-Formed Extra Support Guidewire 510(k) K211741 - FDA.report, Pre-Formed Extra Support Guidewire (K211741) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lake Region Medical

Sources (1)

  • FDA 510(k) K211741 24 fields · synced Oct 6, 2026