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Medtronic Models 6907/6901 Permanent Pacemaker Electrode

FDA 510(k)

Class III (US FDA 510(k))

510(k) K790766

by Medtronic Vascular

Identifiers

510(k) Number
K790766 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 Models 6907/6901 are classified as Permanent Pacemaker Electrodes, designed for implantation to facilitate cardiac pacing. These electrodes interface with pacemaker systems to deliver electrical impulses that regulate heart rhythm in patients with bradycardia or other conduction disorders.

These devices are supplied sterile and intended for single-use implantation within the cardiovascular system. They are regulated under FDA 510(k) clearance (K790766) as Class III medical devices, adhering to strict manufacturing and performance standards. Storage and handling must comply with medical device protocols to maintain sterility and functionality prior to use.

Frequently asked questions

Are these electrodes reusable or intended for single-use, and why does that matter for my procedure?

The Medtronic Models 6907/6901 are intended for single-use only. This is critical because they are supplied sterile and designed for implantation within the cardiovascular system. Reusing them could compromise sterility, increase infection risks, and violate manufacturer guidelines, potentially voiding warranty or liability protections. Single-use also ensures consistent performance and compliance with FDA 510(k) standards for Class III devices.

How should I store these electrodes before use to maintain their integrity?

These electrodes must be stored according to medical device protocols to preserve sterility and functionality. The packaging should remain unopened and sealed until immediate use. Avoid exposure to extreme temperatures, moisture, or contamination. Since they’re sterile upon receipt, any breach of sterility—such as improper handling or prolonged exposure—could render them unsuitable for implantation. Always follow the manufacturer’s storage instructions included with the device.

What clinical scenarios are these electrodes approved for, and how do they work?

These electrodes are approved for use in patients with bradycardia or conduction disorders that require cardiac pacing. They interface with pacemaker systems to deliver regulated electrical impulses, helping to maintain a normal heart rhythm. The design ensures reliable signal transmission between the pacemaker and heart tissue, addressing conditions like heart block or slow heart rates where natural conduction is insufficient.

What regulatory pathway was followed for these electrodes, and what does that mean for my purchase?

The Medtronic Models 6907/6901 were cleared via the FDA 510(k) process under Traditional review, classified as Class III devices. This means they were deemed substantially equivalent to a legally marketed predicate device and meet stringent performance and safety standards. For your purchase, this indicates rigorous testing and compliance with U.S. regulations, though you should verify the specific lot and expiration dates to ensure continued validity.

Are there different models (e.g., 6907 vs. 6901) that I should know about for my patient’s needs?

The 6907 and 6901 are distinct models within the same product line, but the provided data does not specify differences in their design, lead characteristics, or clinical applications. Typically, variations in pacemaker electrodes may relate to lead length, tip configuration, or fixation mechanisms. To select the appropriate model for your patient, consult the manufacturer’s documentation or your cardiology team to ensure compatibility with the intended pacemaker system and anatomical requirements.

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: Medtronic Models 6907 6901 - Medtronic Vascular | FDA Evidence Review, MEDTRONIC MODELS 6907/6901 (K790766) - FDA 510 (k), MEDTRONIC MODELS 6907/6901 (K790766) — FDA 510(k) | Innolitics, Medtronic Models 6907/6901 510 (k) K790766 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K790766 24 fields · synced Oct 6, 2026