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Alternate Sterlization Process & Modified Df-1 Lead Connector (modification)

FDA 510(k)

Class III (US FDA 510(k))

510(k) K954092

by Medtronic Vascular

Identifiers

510(k) Number
K954092 FDA 510(k)
FDA Product Code
DXY FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3610 FDA 510(k)
Regulation Number
870.3610 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

This device is a modified DF-1 Lead Connector, classified under the nomenclature for Implantable Pacemaker Pulse-Generator components. It serves as a specialized connector designed to interface with pacemaker leads, facilitating electrical continuity and mechanical stability within cardiovascular implant systems.

The Modified DF-1 Lead Connector is supplied as a single-use component, adhering to an alternate sterilization process as documented in the FDA 510(k) submission (K954092). It is intended for use in sterile environments during pacemaker lead implantation procedures and is subject to tracking under the FDA’s regulatory framework for Class III devices (DXY). No MRI safety or reusable specifications are noted in the regulatory data.

Frequently asked questions

What is the primary purpose of the Modified DF-1 Lead Connector in pacemaker systems?

The Modified DF-1 Lead Connector is designed to interface with pacemaker leads, ensuring both electrical continuity and mechanical stability within cardiovascular implant systems. It acts as a critical component to maintain proper function and reliability of the pacemaker lead during implantation.

Is this device intended for reuse, or is it meant to be used only once?

This device is explicitly supplied as a single-use component. It is intended for sterile use during pacemaker lead implantation procedures and is not designed for reuse, as outlined in the FDA 510(k) submission.

How is the sterility of the Modified DF-1 Lead Connector ensured?

The device undergoes an alternate sterilization process, which is documented in the FDA 510(k) submission (K954092). This ensures it remains sterile for use in sterile environments during pacemaker lead implantation, adhering to regulatory requirements for Class III medical devices.

What regulatory pathway was followed for this device’s approval, and which committee reviewed it?

The Modified DF-1 Lead Connector was cleared through the traditional 510(k) pathway under FDA’s Cardiovascular (CV) Advisory Committee. It is classified as a Class III device under product code DXY and is subject to tracking under the FDA’s regulatory framework.

Are there any specific storage requirements or considerations for this device?

While the provided data does not specify exact storage conditions, the device is intended for sterile use and must be handled in accordance with standard medical device sterilization and packaging guidelines. Since it is single-use, it should be stored in its original packaging until ready for immediate use in a sterile field.

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) K954092 24 fields · synced Oct 6, 2026