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Models 2411/2418 Ventricular-Inhibited Implantable Pacemaker Pulse-Generator

FDA 510(k)

Class III (US FDA 510(k))

510(k) K791093

by Medtronic Vascular

Identifiers

510(k) Number
K791093 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)

The Models 2411/2418 are ventricular-inhibited implantable pacemaker pulse-generators, designed to regulate heart rhythm by delivering electrical impulses to the heart’s ventricles when spontaneous contractions are detected. These devices fall under the classification of Implantable Pacemaker Pulse-Generators, providing pacing support for patients with bradycardia or conduction system disorders.

These pulse-generators are intended for surgical implantation and are classified as Class III medical devices under FDA regulations, with a 510(k) clearance (K791093) granted in 1979. They are reusable, non-sterile devices supplied for use in clinical settings by qualified healthcare professionals. No specific MRI safety information or sterility requirements are noted in the regulatory data.

Frequently asked questions

Are these devices intended for single-use or can they be reused in multiple patients?

These Models 2411/2418 ventricular-inhibited pacemaker pulse-generators are explicitly labeled as reusable devices. They are supplied non-sterile for use in clinical settings by qualified healthcare professionals, meaning they are designed to be implanted in individual patients and remain in place as a long-term solution, not for reuse across multiple patients.

What types of patients are these devices primarily intended to support?

These devices are designed to regulate heart rhythm by delivering electrical impulses to the heart’s ventricles when spontaneous contractions are not detected. They are intended for patients with bradycardia (slow heart rate) or conduction system disorders, providing pacing support to maintain proper heart function.

How are these devices supplied, and what should clinicians consider regarding sterility?

The Models 2411/2418 are supplied non-sterile and are intended for surgical implantation by qualified healthcare professionals. Since they are reusable and remain implanted long-term, sterility is not a requirement for the device itself, but standard surgical aseptic techniques must be followed during implantation to ensure patient safety.

What regulatory pathway was followed for clearance of these devices, and which advisory committee was involved?

These devices received FDA clearance through a traditional 510(k) pathway, specifically under the classification of Implantable Pacemaker Pulse-Generators. The review was conducted by the Cardiovascular (CV) Advisory Committee, and the clearance was granted in 1979 under the product code DXY, confirming substantial equivalence to a predicate device.

Are there any special considerations for storage or handling of these devices?

While the data does not specify storage conditions, as reusable and non-sterile devices, these pulse-generators should be stored in a clean, dry environment to prevent contamination or damage. Since they are intended for surgical implantation, they should be handled in accordance with standard medical device protocols to maintain their integrity until use.

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) K791093 24 fields · synced Oct 6, 2026