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Ventricular Lead, Model 6959

FDA 510(k)

Class III (US FDA 510(k))

510(k) K790143

by Medtronic Vascular

Identifiers

510(k) Number
K790143 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 Ventricular Lead, Model 6959 is a permanent pacemaker electrode designed for implantation within the heart’s ventricular chamber. It facilitates cardiac pacing by delivering electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders.

This device is supplied as a reusable, non-sterile component intended for surgical implantation by qualified healthcare professionals. It is classified under product code DTB and has received FDA 510(k) clearance (K790143) as a Class III device, with regulatory oversight under 21 CFR 870.3680. Storage and handling must comply with manufacturer guidelines to ensure proper functionality and patient safety.

Frequently asked questions

Is this ventricular lead intended for single-use or can it be reused after implantation?

This ventricular lead (Model 6959) is explicitly designed as a reusable component for surgical implantation. It is supplied in a non-sterile state, meaning it must be sterilized by the healthcare facility prior to use. Reuse is permitted only after proper cleaning, sterilization, and adherence to manufacturer guidelines to ensure patient safety and device functionality.

What storage and handling requirements should I follow for this device before use?

Since this lead is non-sterile, it must be sterilized by the healthcare facility before implantation. Storage and handling must comply with Medtronic’s guidelines to prevent contamination or damage. The device should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until sterilization. Always follow the manufacturer’s instructions to maintain its integrity and ensure safe use.

What regulatory pathway was followed for this ventricular lead’s approval, and which committee reviewed it?

This device received FDA 510(k) clearance (K790143) under the traditional review pathway, classified as a Class III medical device. The Cardiovascular (CV) Advisory Committee reviewed the submission, which was filed under product code DTB and falls under regulatory oversight of 21 CFR 870.3680. The decision was based on substantial equivalence to a predicate device.

How is this ventricular lead different from other pacemaker electrodes in terms of its intended use?

This Model 6959 is specifically designed as a permanent pacemaker electrode for implantation within the ventricular chamber of the heart. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders, ensuring consistent pacing support. Unlike some leads that may target different heart chambers, this one is focused solely on ventricular function.

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: Ventricular Lead Model 6959 - Medtronic Vascular | FDA Evidence Review, VENTRICULAR LEAD, MODEL 6959 (K790143) - FDA 510 (k), VENTRICULAR LEAD, MODEL 6959 (K790143) — FDA 510(k) | Innolitics, Medtronic Temporary Sensing and Pacing Leads

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K790143 24 fields · synced Oct 6, 2026