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Pulse Generators, Models 5988/5989

by Medtronic Vascular

510(k) K781208

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 NumberK781208 Date3 Oct 1978ClearedStatusActive

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  • Withdrawn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
Generators, Pulse, Models 5988/5989
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 Pulse Generators, Models 5988/5989, are implantable pacemaker pulse-generators designed to deliver electrical impulses to regulate heart rhythm. These devices are classified as Implantable Pacemaker Pulse-Generators and are intended for use in cardiovascular applications to manage bradycardia or other cardiac conduction disorders.

These pulse generators are supplied sterile and intended for single-use implantation within the human body. They are regulated under FDA 510(k) clearance (K781208) and fall under device classification DXY, with a traditional review pathway through the Cardiovascular Advisory Committee. Models 5988 and 5989 are not specified for MRI safety in the provided data and require proper storage and handling as per manufacturer guidelines.

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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 clinical purpose of the Pulse Generators, Models 5988/5989, and how do they function in the body?

    The Pulse Generators, Models 5988/5989, are designed to regulate heart rhythm by delivering electrical impulses to treat bradycardia or other cardiac conduction disorders. These implantable devices are placed within the body to stimulate the heart when its natural electrical system fails to maintain an adequate rate or rhythm.

  • Are these pulse generators intended for single-use or reusable implantation, and how should they be handled before use?

    These pulse generators are explicitly intended for single-use implantation. They are supplied sterile, so they must be handled using aseptic techniques to maintain sterility until implantation. Proper storage and handling per manufacturer guidelines are critical to ensure device integrity.

  • What regulatory pathway was followed for FDA clearance of these pulse generators, and which advisory committee was involved?

    The Pulse Generators, Models 5988/5989, underwent a traditional review pathway through the FDA’s Cardiovascular (CV) Advisory Committee. The clearance was granted under the 510(k) premarket notification process, with a decision code indicating they were determined to be substantially equivalent to a predicate device.

  • Can these pulse generators be used in patients who require MRI scans, and what considerations should be made?

    The provided data does not specify MRI safety for Models 5988 and 5989. If MRI is required for a patient with these devices, strict adherence to manufacturer guidelines is essential to avoid risks associated with electromagnetic interference or device malfunction.