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Models 5069/5071 Myocardial Pacing Leads

FDA 510(k)

Class III (US FDA 510(k))

510(k) K902002

by Medtronic Vascular

Identifiers

510(k) Number
K902002 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 Models 5069/5071 Myocardial Pacing Leads are classified as Permanent Pacemaker Electrodes, designed for use in temporary cardiac pacing. These leads are intended to deliver electrical impulses to stimulate the heart muscle, ensuring proper heart rhythm during temporary pacing procedures.

These leads are supplied sterile and are intended for single-use. They are regulated under FDA 510(k) clearance (K902002) and fall under the Class III medical device category. The devices are manufactured by Medtronic Vascular and are intended for use in controlled clinical settings, adhering to strict sterility and handling protocols.

Frequently asked questions

Are these leads intended for permanent or temporary cardiac pacing, and how does that affect their use case?

These leads (Models 5069/5071) are specifically designed for temporary cardiac pacing, not permanent implantation. They deliver electrical impulses to stimulate the heart muscle during short-term procedures where temporary pacing support is required, such as post-surgery recovery or acute bradycardia management. Their temporary use ensures compatibility with controlled clinical settings where they can be removed once the patient’s heart rhythm stabilizes.

How should these leads be handled and stored to maintain sterility, given they are single-use?

The leads are supplied sterile and intended for single-use only, meaning they must remain unopened until immediate use. Storage should follow manufacturer guidelines to preserve sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, they should be used promptly and discarded after a single procedure to prevent contamination or compromise of sterility.

What regulatory pathway was followed for FDA clearance, and how does that impact their clinical use?

These leads were cleared via the FDA 510(k) process (K902002), classified under Class III with a substantially equivalent (SESE) determination. This pathway confirms they meet FDA standards for safety and effectiveness as a Permanent Pacemaker Electrode (though intended for temporary use). Clinically, this clearance ensures they adhere to rigorous manufacturing and performance standards, but their temporary designation means they’re not meant for long-term implantation.

Are there multiple models or sizes available, and if so, how do I determine which one to use?

The data lists two models (5069/5071), but specific sizing details (e.g., electrode length, diameter, or tip configurations) aren’t provided here. Typically, selection would depend on the patient’s anatomy, pacing requirements, and the clinician’s preference for lead placement (e.g., right ventricular apex vs. septal). Consulting the manufacturer’s product documentation or a Medtronic representative is recommended to match the lead to the procedure’s needs.

How do I confirm compatibility with temporary pacing systems before ordering?

Compatibility is ensured through the FDA 510(k) clearance, which validates these leads work as intended with temporary pacing systems under the specified use case. However, to confirm exact compatibility with your specific pacing device, check the manufacturer’s product compatibility lists or technical specifications. Medtronic’s documentation should outline which pacing systems are supported, as temporary leads must interface correctly with the external or implantable pulse generator being used.

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: Models 5069 5071 Myocardial Pacing Leads - Medtronic Vascular | FDA ..., medtronic models 5069 and 5071 myocardial pacing, Models 5069/5071 Myocardial Pacing Leads, K902002 FDA 510(k) - MODELS 5069/5071 MYOCARDIAL 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) K902002 24 fields · synced Oct 6, 2026