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Medtronic Model 2409 Implantable Pacemaker Pulse-Generator

by Medtronic Vascular 2 variants

510(k) K800226

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800226 Date9 Sep 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Medtronic Model 2409
510(k) Number
FDA product code
DXY
Device class
Class III
Regulation
21 CFR Part 870.3610
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medtronic Model 2409 is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other cardiac conduction disorders requiring chronic pacing support, functioning as a life-sustaining device for sustained cardiac function.

This device is supplied as a reusable, non-sterile medical instrument and is regulated under FDA 510(k) clearance (K800226) as a Class 3 Cardiovascular product (DXY code). It is intended for clinical use in controlled environments such as hospitals or cardiac care units, with no indication of MRI compatibility or single-use specifications. Authorized for use in the United States, it adheres to regulatory standards outlined in 21 CFR 870.3610.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Medtronic Model 2409 Implantable Pacemaker Pulse-Generator, and who is it designed for?

    The Medtronic Model 2409 is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle, serving as a life-sustaining device for patients with bradycardia or other cardiac conduction disorders requiring chronic pacing support. It is intended for use in controlled clinical environments like hospitals or cardiac care units.

  • Is the Medtronic Model 2409 intended for single-use or reusable applications, and what are its sterility specifications?

    The Medtronic Model 2409 is supplied as a reusable, non-sterile medical instrument. It is not intended for single-use, and its non-sterile nature means it must be handled and processed according to clinical protocols to ensure patient safety before implantation.

  • What regulatory pathway does the Medtronic Model 2409 follow, and where is it authorized for use?

    The Medtronic Model 2409 is regulated under the FDA 510(k) clearance pathway as a Class 3 Cardiovascular device (product code DXY) and is authorized for use in the United States. It adheres to regulatory standards outlined in 21 CFR 870.3610, ensuring compliance with U.S. medical device regulations.

  • Does the Medtronic Model 2409 have any special considerations for use in imaging environments like MRI?

    The provided data does not mention MRI compatibility for the Medtronic Model 2409. Clinicians should consult Medtronic’s official documentation or safety guidelines before using this device in proximity to MRI machines, as pacemakers can pose risks in magnetic fields.