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Models 4012/4512 Transvenous Tined-

FDA 510(k)

Class III (US FDA 510(k))

510(k) K842032

by Medtronic Vascular

Identifiers

510(k) Number
K842032 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 4012/4512 Transvenous Tined Lead is a permanent pacemaker electrode designed for transvenous implantation. These leads are intended for use in cardiac pacing systems to deliver electrical impulses to the heart, facilitating rhythm regulation in patients requiring pacemaker therapy. They feature tined fixation to ensure stable positioning within the venous system.

These leads are supplied sterile and intended for single-use implantation by healthcare professionals in clinical settings such as cardiac catheterization labs or operating rooms. They are classified under FDA product code DTB and have received FDA 510(k) clearance for use in cardiovascular applications. The devices are manufactured by Medtronic Vascular and adhere to regulatory standards for permanent pacemaker electrodes, ensuring compatibility with pacing systems and patient safety.

Frequently asked questions

Are the Models 4012/4512 Transvenous Tined Leads reusable or intended for single-use only? Why does this matter for my procedure planning?

The Models 4012/4512 Transvenous Tined Leads are sterile and intended for single-use only, as explicitly stated in the device description. This matters because single-use leads eliminate the risk of cross-contamination between patients, reducing infection risks in cardiac procedures. Reusing these leads is not recommended, as it could compromise sterility and patient safety, particularly in sensitive transvenous implantations.

What types of clinical settings are these leads designed for, and how should they be handled during implantation?

These leads are designed for clinical settings such as cardiac catheterization labs or operating rooms, where sterile conditions can be maintained. They are supplied sterile and must be handled using aseptic techniques during transvenous implantation to ensure patient safety. The tined fixation mechanism requires precise placement, so the procedure should be performed by trained healthcare professionals familiar with pacemaker electrode implantation.

What regulatory pathway was followed for FDA clearance of these leads, and what does this mean for compatibility with pacing systems?

The Models 4012/4512 Transvenous Tined Leads received FDA 510(k) clearance under product code DTB, with a decision classified as *Substantially Equivalent* to prior devices. This means they meet regulatory standards for permanent pacemaker electrodes and are designed to be compatible with approved cardiac pacing systems. The clearance ensures they adhere to safety and performance requirements for transvenous use, validating their reliability for rhythm regulation in patients.

How do I determine the correct size or model for a patient, and are there variations between the 4012 and 4512?

The 4012 and 4512 models are distinct variants of the same lead family, but the data provided does not specify exact size differences (e.g., coil length, electrode spacing, or tine configuration). Typically, selection depends on clinical factors like venous anatomy, pacing requirements, and physician preference. Consult the manufacturer’s technical documentation or a Medtronic representative to confirm compatibility with your patient’s needs, as these details are not detailed in the provided regulatory data.

What storage requirements should I follow for these leads to maintain their sterility and functionality?

While the data does not specify exact storage conditions, sterile medical devices like these leads generally require protection from moisture, extreme temperatures, and physical damage. They should be stored in their original, sealed packaging until use, in a clean, dry environment away from direct sunlight or heat sources. Always follow Medtronic’s instructions for storage to preserve sterility and ensure proper functionality before implantation.

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 4012/4512 TRANSVENOUS TINED- (K842032) - FDA 510(k), Models 4012 4512 Transvenous Tined - Medtronic Vascular | FDA Reference, K832099 FDA 510 (k) - MEDTRONIC MODELS 4012 & 4512, MEDTRONIC MODELS 4012 & 4512 (K832099) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K842032 24 fields · synced Oct 6, 2026