Medtronic Models 4012 & 4512 Permanent Pacemaker Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K832099 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 4012 & 4512 are transvenous tined leads classified as Permanent Pacemaker Electrodes. These devices are designed to be implanted via the venous system, delivering electrical impulses to regulate cardiac rhythm within pacemaker systems.
These electrodes are supplied sterile and intended for single-use. They are regulated under FDA 510(k) clearance (K832099) as Class 3 Cardiovascular devices under product code DTB. The devices are manufactured by Medtronic Vascular and comply with traditional 510(k) review standards.
Frequently asked questions
Are the Medtronic Models 4012 & 4512 leads designed for reuse in multiple patients, or are they intended for single-use only?
The Medtronic Models 4012 & 4512 are explicitly supplied sterile and intended for single-use only. This is a standard practice for transvenous tined leads to ensure patient safety and prevent cross-contamination, as outlined in the device description.
What is the primary purpose of these leads, and how are they implanted in the body?
These leads are permanent pacemaker electrodes designed to be implanted via the venous system. They deliver electrical impulses to regulate cardiac rhythm as part of a pacemaker system, ensuring proper heart function in patients with arrhythmias or conduction disorders.
How are these devices regulated in the U.S., and what type of review process did they undergo?
The Medtronic Models 4012 & 4512 are classified as Class 3 Cardiovascular devices under FDA product code DTB and were cleared via a Traditional 510(k) review (K832099). They were determined to be *substantially equivalent* to a predicate device, with the review conducted by the Cardiovascular (CV) Advisory Committee.
Are there multiple sizes or models available for these leads, or is there a single configuration?
The data provided does not specify distinct sizes or configurations beyond the two listed models (4012 & 4512), which are both transvenous tined leads for permanent pacemaker systems. Clinicians should refer to Medtronic’s technical documentation for model-specific details like lead length or electrode placement options.
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 4012 4512 - Medtronic Vascular | FDA Evidence Review, K832099 FDA 510 (k) - MEDTRONIC MODELS 4012 & 4512, Models 4012 4512 Transvenous Tined - Medtronic Vascular | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K832099 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K832099 24 fields · synced Oct 6, 2026