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Medtronic Model 4058 Pacing Lead

FDA 510(k)

Class III (US FDA 510(k))

510(k) K883743

by Medtronic Vascular

Identifiers

510(k) Number
K883743 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 4058 Pacing Lead is a Permanent Pacemaker Electrode, designed to deliver electrical stimulation to the heart for the treatment of bradycardia or other cardiac rhythm disorders. This device is intended for implantation within the cardiac chambers to regulate heart rate through synchronized pacing signals, ensuring proper cardiac function in patients requiring long-term pacing support.

This pacing lead 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 is classified as a Class III medical device under FDA regulations and has received FDA 510K clearance as substantially equivalent to a predicate device. The lead is compatible with standard pacemaker systems and must be handled under aseptic conditions prior to use, adhering to manufacturer guidelines for storage and preparation.

Frequently asked questions

What is the primary clinical purpose of the Medtronic Model 4058 Pacing Lead, and how is it intended to be used in a patient setting?

The Medtronic Model 4058 Pacing Lead is designed to deliver electrical stimulation to the heart for managing bradycardia or other cardiac rhythm disorders. It is implanted within the cardiac chambers to regulate heart rate through synchronized pacing signals, providing long-term pacing support for patients who require consistent cardiac function regulation. This lead is intended for use in clinical settings like cardiac catheterization labs or operating rooms by qualified healthcare professionals.

Is the Medtronic Model 4058 Pacing Lead intended for single-use or reusable applications, and what are the handling requirements?

The Medtronic Model 4058 Pacing Lead is supplied sterile and intended for single-use implantation only. Due to its sterile packaging and clinical application, it must be handled under aseptic conditions prior to use, following the manufacturer’s guidelines for storage and preparation to ensure patient safety and device integrity.

What regulatory pathway was followed for FDA clearance of this pacing lead, and which advisory committee was involved?

The Medtronic Model 4058 Pacing Lead received FDA clearance through a Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations for permanent pacemaker electrodes.

Where is this device manufactured, and what are the key details about its regulatory filing history?

The device is manufactured by Medtronic Vascular at their facility located at 7000 Central Ave. NE, Minneapolis, MN 55432. The initial FDA 510(k) submission was filed on September 1, 1988, and clearance was granted on January 17, 1989, under the product code DTB for permanent pacemaker electrodes. The filing was reviewed by the Cardiovascular Advisory Committee.

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

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K883743 24 fields · synced Oct 6, 2026