← Back to catalogue

Medtronic #6993 Permanent Pacemaker Electrode

FDA 510(k)

Class III (US FDA 510(k))

510(k) K820989

by Medtronic Vascular

Identifiers

510(k) Number
K820989 FDA 510(k)
FDA Product Code
DTB FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medtronic #6993 is a Permanent Pacemaker Electrode, a device designed for implantation to stimulate the heart and regulate cardiac rhythm in patients with bradycardia or other conduction disorders. It delivers electrical impulses via leads positioned within the heart chambers, ensuring proper pacing and synchronization of contractions. Constructed for long-term use, it integrates with pacemaker systems to restore and maintain normal heart function.

This electrode is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings such as cardiac catheterization labs or operating rooms. It adheres to FDA 510(k) clearance under the Cardiovascular advisory committee and falls under Device Class III per regulatory classification. Compatible with MRI environments under specific conditions (as defined by the manufacturer’s instructions), it requires proper handling, sterile storage, and adherence to manufacturer guidelines for optimal performance and patient safety.

Frequently asked questions

What is the primary purpose of the Medtronic #6993 Permanent Pacemaker Electrode, and how does it function in the body?

The Medtronic #6993 is designed to stimulate the heart and regulate cardiac rhythm in patients with bradycardia or conduction disorders. It delivers electrical impulses through leads placed within the heart chambers, working in tandem with a pacemaker system to ensure proper pacing and synchronization of heart contractions, thereby maintaining normal heart function over the long term.

Is the Medtronic #6993 intended for reuse, or is it meant to be used only once after implantation?

The device is explicitly intended for single-use implantation by qualified healthcare professionals. It is supplied sterile and should not be reused, as this could compromise patient safety and device performance.

What type of storage conditions are required for the Medtronic #6993 before implantation?

The device must be stored under sterile conditions to maintain its integrity. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until ready for use, following the manufacturer’s guidelines to prevent contamination or damage.

Can this device be used in patients who require MRI scans, and if so, are there specific conditions or restrictions?

Yes, the Medtronic #6993 is compatible with MRI environments under specific conditions. However, its use in MRI requires strict adherence to the manufacturer’s instructions to ensure patient safety, as improper handling could pose risks.

What regulatory pathway was followed for the FDA clearance of the Medtronic #6993, and which advisory committee was involved?

The device was cleared through the FDA 510(k) pathway, specifically under the Cardiovascular (CV) Advisory Committee. It was determined to be substantially equivalent to a predicate device, and the clearance was granted on August 6, 1982, under the Traditional 510(k) review process.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K820989 24 fields · synced Oct 6, 2026