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Medtronic Model 6971 Permanent Pacemaker Electrode

FDA 510(k)

Class III (US FDA 510(k))

510(k) K790074

by Medtronic Vascular

Identifiers

510(k) Number
K790074 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 6971 is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to facilitate cardiac pacing. This device delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring proper cardiac function through direct myocardial stimulation.

Implanted via a minimally invasive procedure, the Model 6971 is intended for single-use and is classified as a Class 3 medical device under FDA regulation 870.3680. It is supplied sterile and requires proper handling and storage to maintain integrity before and after implantation. Authorized under FDA 510(k) clearance K790074, this device adheres to traditional review standards and is categorized under product code DTB for cardiovascular applications.

Frequently asked questions

What is the Medtronic Model 6971 used for in clinical practice?

The Medtronic Model 6971 is a permanent pacemaker electrode designed to regulate heart rhythm by delivering electrical impulses directly to the heart muscle (myocardium). It is specifically intended for patients with bradycardia or conduction disorders, ensuring proper cardiac function through chronic myocardial stimulation. Implantation is performed via a minimally invasive procedure.

Is the Medtronic Model 6971 intended for reuse, or is it single-use only?

The Medtronic Model 6971 is explicitly labeled for single-use only. It is supplied sterile and must not be reused after implantation to maintain safety and efficacy, as reuse could compromise sterility and device integrity.

How should the Medtronic Model 6971 be stored to preserve its sterility and functionality?

The device must be stored in its original packaging under controlled conditions to maintain sterility and integrity. Since it is sterile upon receipt, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use. Always follow manufacturer guidelines for storage duration and handling.

What regulatory pathway was followed for FDA clearance of the Medtronic Model 6971?

The Medtronic Model 6971 received FDA clearance through a 510(k) submission (K790074) under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE). It falls under product code DTB for cardiovascular devices and was reviewed by the Cardiovascular (CV) Advisory Committee. The device is classified as a Class 3 under FDA regulation 870.3680.

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 6971 - Medtronic Vascular | FDA Evidence Review, K790074 - MEDTRONIC MODEL 6971 | FDA 510(k) | Medtronic Vascular, Medtronic Model 6971 510 (k) K790074 - FDA.report, Medtronic Model 6971 510 (k) K790074 - 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) K790074 24 fields · synced Oct 6, 2026