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Alternate Package Config. For Implant. Pulse Gen.

FDA 510(k)

Class III (US FDA 510(k))

510(k) K862974

by Medtronic Vascular

Identifiers

510(k) Number
K862974 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
SESE Substantially Equivalent FDA 510(k)

This device is an Implantable Pacemaker Pulse-Generator, classified under product code DXY. It is designed to generate electrical impulses for regulating heart rhythm in patients with bradycardia or other cardiac conduction disorders, serving as a critical component in pacemaker systems for sustained cardiac function.

The device is supplied in an alternate package configuration and is intended for surgical implantation. It is regulated under FDA 510(k) clearance (K862974) as a Class III medical device, requiring premarket approval due to its high-risk, life-sustaining nature. No details regarding sterility, single-use, or MRI safety are provided in the available data.

Frequently asked questions

What is the primary purpose of this device in a clinical setting?

This device is an Implantable Pacemaker Pulse-Generator, designed to deliver electrical impulses that regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. It serves as a critical component in pacemaker systems to maintain sustained cardiac function by compensating for abnormal heartbeats.

How is this device supplied, and what does the 'alternate package configuration' refer to?

The device is supplied in an alternate package configuration, meaning it may come in a different packaging design compared to standard versions. While the exact differences aren’t detailed, this likely refers to variations in packaging materials, size, or layout to accommodate specific surgical or storage needs. It is intended for surgical implantation as part of a pacemaker system.

Is this device single-use or reusable, and what are the sterility considerations?

The provided data does not specify whether this device is single-use or reusable, nor does it mention sterility requirements. Implantable pulse generators are typically sterile and intended for one-time surgical use in clinical practice, but this should be confirmed with the manufacturer or regulatory documentation for your specific use case.

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

This device was cleared under the FDA 510(k) pathway (K862974) as a Class III medical device, requiring premarket approval due to its high-risk, life-sustaining nature. The Cardiovascular (CV) Advisory Committee reviewed the submission, and the decision was classified as Substantially Equivalent (SESE) under the traditional clearance process.

Are there multiple models or sizes available for this device, and how would I identify them?

The data lists multiple FEI numbers (e.g., 3002807576, 2017865, etc.), which likely correspond to different models or variants of this pulse generator. These identifiers are used in FDA registrations and may reflect variations in specifications, such as battery capacity, programming features, or lead compatibility. For exact sizing or model details, refer to the manufacturer’s documentation or contact Medtronic Vascular directly.

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: K862974 FDA 510(k) - ALTERNATE PACKAGE CONFIG. FOR IMPLANT. ..., Alternate Package Config. for Implant. Pulse Gen., Alternate Package Config. For Implant. Pulse Gen… - FDA.report, Medtronic Vascular Alternate Package Config. For Implant…, Medtronic Manuals: Home

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K862974 24 fields · synced Oct 6, 2026