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Pre-Formed Blue

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221575

by Lake Region Medical

Identifiers

510(k) Number
K221575 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 Blue is a guidewire classified as a wire, guide, catheter. It is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.

This device is manufactured by Lake Region Medical and received FDA 510(k) clearance under K221575 on October 7, 2022. It is categorized as a Class II medical device subject to special controls.

Frequently asked questions

What is the primary clinical use of the Pre-Formed Blue guidewire?

This device is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart. It is specifically designed to support procedures such as transcatheter aortic valve interventions.

How is the Pre-Formed Blue classified for regulatory purposes?

The Pre-Formed Blue is classified as a Class II medical device. It received FDA 510(k) clearance under K221575 on October 7, 2022, and is subject to special controls as a wire, guide, catheter.

Who is the manufacturer of the Pre-Formed Blue guidewire?

The device is manufactured by Lake Region Medical, located in Chaska, Minnesota. The company submitted the device for FDA clearance, which was granted in October 2022.

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: Pre-Formed Blue by Lake Region Medical | FDA 510(k) Summary, K221575 FDA 510(k) - Pre-Formed Blue | Lake Region Medical, Pre-Formed Blue — FDA 510 (k) K221575 | MedTracker, PDF K221575 - Pre-Formed Blue

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) K221575 24 fields · synced Oct 6, 2026