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Alternate Packaging Configuration for Pacing Leads

FDA 510(k)

Class III (US FDA 510(k))

510(k) K890527

by Medtronic Vascular

Identifiers

510(k) Number
K890527 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 under the nomenclature for cardiovascular pacing leads. It is designed to deliver electrical impulses to the heart for the treatment of cardiac rhythm disorders, ensuring proper pacing and synchronization of cardiac contractions.

The device is supplied in an alternate packaging configuration and is intended for single-use. It is regulated under FDA 510K clearance with a Traditional clearance type, falling under Device Class III (regulation number 870.3680). Packaging configurations are tailored for compatibility with existing pacemaker systems, adhering to strict sterility standards for surgical use.

Frequently asked questions

What is the primary purpose of this alternate packaging configuration for pacing leads, and how does it differ from standard packaging?

This alternate packaging configuration is designed for permanent pacemaker electrodes, which deliver electrical impulses to the heart to manage cardiac rhythm disorders. The key difference from standard packaging lies in its tailored compatibility with existing pacemaker systems, ensuring seamless integration while maintaining strict sterility standards for surgical use. It remains a single-use device, adhering to the same core function but optimized for specific system requirements.

Are these pacing leads reusable, or are they intended for single-use only? What does this mean for clinical workflow?

These pacing leads are intended for single-use only, as explicitly stated in the device description. This means each lead is sterile, pre-packaged, and designed to be used once per patient to minimize infection risk and ensure reliability. Clinically, this simplifies inventory management and reduces the need for reprocessing, aligning with best practices for sterile medical devices.

What regulatory pathway was followed for this alternate packaging configuration, and what class does it fall under?

This device followed the FDA 510K pathway with a Traditional clearance type, classified under Device Class III (regulation number 870.3680). The

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) K890527 24 fields · synced Sep 18, 2026