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Implantable Tined, Trans. Pacing Lead/Revis. Label

FDA 510(k)

Class III (US FDA 510(k))

510(k) K871333

by Medtronic Vascular

Identifiers

510(k) Number
K871333 FDA 510(k)
FDA Product Code
DTB FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a permanent pacemaker electrode, classified as an implantable transvenous pacing lead designed for cardiac rhythm management. It delivers electrical impulses to stimulate the heart, ensuring proper pacing and synchronisation in patients with bradycardia or conduction disorders. The lead is intended for use in revision procedures or as a replacement for existing leads, maintaining long-term pacing functionality.

The lead is supplied sterile and intended for single-use implantation via the venous system, typically positioned in the right atrium or ventricle. It is regulated under FDA 510(k) clearance (K871333) and falls under device classification 3, adhering to regulatory standards for cardiovascular devices. Storage requires adherence to manufacturer guidelines for sterile packaging, and compatibility with MRI environments must be confirmed prior to use. Sizes and configurations are specified in the accompanying documentation.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K871333 24 fields · synced Oct 6, 2026