← Back to catalogue

Medtronic Model 6957 Permanent Pacemaker Electrode

FDA 510(k)

Class III (US FDA 510(k))

510(k) K790429

by Medtronic Vascular

Identifiers

510(k) Number
K790429 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 Model 6957 is a unipolar screw-in lead classified as a Permanent Pacemaker Electrode (product code DTB). This device is designed for implantation in the heart to facilitate cardiac pacing, providing electrical stimulation to regulate heart rhythm in patients requiring chronic pacing support.

This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in a clinical setting. It is regulated under FDA 510(k) clearance (K790429) and falls under Class III medical device classification. The electrode is intended for use with compatible pacemaker systems and adheres to strict manufacturing and sterility standards for cardiac implantable devices.

Frequently asked questions

What is the primary purpose of the Medtronic Model 6957 and how does it function in a patient’s body?

The Medtronic Model 6957 is a unipolar screw-in lead designed specifically for permanent cardiac pacing. It is implanted in the heart to deliver electrical stimulation, helping regulate abnormal heart rhythms in patients who require chronic pacing support. The screw-in mechanism ensures secure fixation within the cardiac chamber, ensuring reliable electrical conduction between the lead and the pacemaker system.

Is the Medtronic Model 6957 intended for reuse, or is it meant to be used only once?

The Medtronic Model 6957 is explicitly intended for single-use implantation only. It is supplied sterile and designed for one-time use by qualified healthcare professionals in a clinical setting, adhering to strict sterility standards for cardiac implantable devices.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

The Medtronic Model 6957 received FDA 510(k) clearance (K790429) under the Traditional pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for permanent pacemaker electrodes. Clinicians can rely on this clearance as evidence of regulatory review for its intended use in cardiac pacing.

How should the Medtronic Model 6957 be stored before use, and what precautions should be taken?

While the device data does not specify storage conditions, as a sterile, single-use cardiac implantable lead, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediate use to maintain sterility and integrity. Always follow manufacturer guidelines (available in the product documentation) for proper handling and expiration checks.

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 Model 6957 - Medtronic Vascular | FDA Evidence Review, K790429 - MEDTRONIC MODEL 6957 | FDA 510(k) | Medtronic Vascular, MEDTRONIC MODEL 6957 (K790429) — FDA 510(k) | Innolitics, MEDTRONIC MODEL 6957 (K791769) - FDA 510 (k)

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) K790429 24 fields · synced Oct 6, 2026