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Medtronic Models 69914/699OU Permanent Pacemaker Electrode

FDA 510(k)

Class III (US FDA 510(k))

510(k) K791667

by Medtronic Vascular

Identifiers

510(k) Number
K791667 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 Models 69914/699OU are permanent pacemaker electrodes, designed for implantation to deliver electrical stimulation to the heart. These devices are classified as Class III medical devices under product code DTB, intended for use in cardiovascular applications requiring chronic cardiac pacing support.

These electrodes are supplied sterile and intended for single-use implantation in a clinical setting. They are regulated under FDA 510(k) clearance (K791667) and comply with regulation number 870.3680. The devices were cleared in 1979 and are intended for use in procedures requiring reliable, long-term cardiac pacing functionality.

Frequently asked questions

What is the primary purpose of the Medtronic Models 69914/699OU electrodes in clinical practice?

These electrodes are designed for permanent implantation to provide chronic cardiac pacing support. They deliver reliable, long-term electrical stimulation to the heart, which is essential for patients requiring sustained pacing therapy in cardiovascular applications.

Are the Medtronic Models 69914/699OU electrodes intended for reuse, or are they single-use only?

The electrodes are explicitly intended for single-use implantation in a clinical setting. They are supplied sterile and should not be reused after implantation to ensure patient safety and device efficacy.

How are these electrodes regulated, and what does the FDA clearance indicate about their use?

The Medtronic Models 69914/699OU electrodes are classified as Class III medical devices under product code DTB and were cleared via an FDA 510(k) pathway (K791667) in 1979. The clearance indicates they are deemed *substantially equivalent* to a legally marketed device for use in procedures requiring reliable, long-term cardiac pacing.

What storage or handling precautions should be taken with these electrodes before implantation?

Since the electrodes are supplied sterile, they must be stored in their original packaging until use to maintain sterility. The packaging should be kept sealed and protected from contamination or damage prior to implantation in a clinical setting.

Are there multiple sizes or models within the 69914/699OU series, or is this a single unified design?

The data provided does not specify distinct sizes or models beyond the two listed (69914 and 699OU), but the registration numbers indicate multiple lot or batch identifiers (e.g., 3002618605, 3008377825) may exist for manufacturing consistency. Clinicians should confirm the exact model and specifications with Medtronic for procedural planning.

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 Models 69914 699OU - Medtronic Vascular | FDA Reference, MEDTRONIC MODELS 69914/699OU (K791667) - FDA 510 (k), PDF K791667 - Medtronic Models 69914/699ou, 510 (k) K791667 — MEDTRONIC MODELS 69914/699OU — RegDataLab

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K791667 24 fields · synced Sep 18, 2026