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Ventricular Inhibited Pulse Generator

FDA 510(k)

Class III (US FDA 510(k))

510(k) K780561

by Medtronic Vascular

Identifiers

510(k) Number
K780561 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 Ventricular Inhibited Pulse Generator is an Implantable Pacemaker Pulse-Generator, classified under product code DXY. This device is designed to deliver electrical impulses to regulate heart rhythm by inhibiting ventricular contractions when intrinsic beats are detected, thereby maintaining proper cardiac pacing in patients with specific arrhythmias.

This device is intended for implantable use and is regulated under FDA 510(k) clearance (K780561) as a Class 3 Cardiovascular device. Supplied sterile and intended for single-use implantation, it adheres to regulatory standards outlined in 21 CFR 870.3610. No additional context on sterility, MRI safety, or reusable components is provided in the specifications.

Frequently asked questions

What is the primary purpose of the Ventricular Inhibited Pulse Generator and how does it function in the body?

The Ventricular Inhibited Pulse Generator is designed to regulate heart rhythm by delivering electrical impulses to inhibit ventricular contractions when the heart naturally generates its own beats. This prevents unnecessary pacing while maintaining proper cardiac function in patients with specific arrhythmias, ensuring only supplemental pacing occurs when needed.

Is this device intended for reuse or single-use, and what does that mean for clinical workflows?

This device is supplied sterile and intended for single-use implantation only, meaning it is not designed to be removed, cleaned, or reused. Clinicians must implant a new unit per patient, ensuring sterility and reducing infection risks. This aligns with standard practices for implantable pacemaker pulse generators.

What regulatory pathway was followed for FDA clearance of this device, and what does that imply for its safety and efficacy?

The Ventricular Inhibited Pulse Generator received FDA 510(k) clearance (K780561) under the Cardiovascular (CV) advisory committee, classified as a Class 3 device and substantially equivalent to a predicate. This pathway ensures the device meets stringent safety and performance standards for implantable cardiac devices, validated through pre-market review by the FDA.

How is this device categorized in terms of its medical specialty and intended use?

This device falls under the Cardiovascular medical specialty and is classified under FDA product code DXY as an *Implantable Pacemaker Pulse-Generator*. While the product code reflects its regulatory filing category (not clinical indication), it confirms the device’s role in managing arrhythmias via ventricular inhibition.

Are there any specific storage requirements or handling instructions for this device before implantation?

The device is supplied sterile, so it must be stored in its original packaging until use to maintain sterility. Since it’s single-use, clinicians should follow standard sterile field protocols for implantable devices, ensuring no contamination occurs prior to implantation. No additional storage conditions (e.g., temperature) are specified in the data.

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: K780561 FDA 510 (k) - VENTRICULAR INHIBITED PULSE GENERATOR, VENTRICULAR INHIBITED PULSE GENERATOR (K780561) — FDA 510(k ..., Ventricular Inhibited Pulse Generator 510(k) K780561 - FDA.report, K780561 FDA 510 (k) - VENTRICULAR INHIBITED PULSE GENERATOR

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K780561 24 fields · synced Oct 6, 2026