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Model 5013 Transvenous Ventricular Pacing Lead

FDA 510(k)

Class III (US FDA 510(k))

510(k) K874792

by Medtronic Vascular

Identifiers

510(k) Number
K874792 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 Model 5013 Transvenous Ventricular Pacing Lead is a permanent pacemaker electrode designed for transvenous placement within the heart’s ventricular chamber. It delivers electrical stimulation to regulate ventricular contractions, supporting patients with bradycardia or other pacing-dependent conditions by maintaining proper heart rhythm.

This lead is intended for single-use implantation via the venous system, requiring sterile handling and aseptic techniques during deployment. It is classified as a Class III device under FDA regulation (product code DTB) and carries an FDA 510(k) clearance (K874792) issued in 1988. Supplied sterile and packaged for clinical use, it adheres to MRI safety guidelines for Class C (safe up to 3 Tesla) and is compatible with standard pacemaker systems.

Frequently asked questions

Is the Model 5013 Transvenous Ventricular Pacing Lead designed for reuse or is it intended for single-use only?

The Model 5013 is explicitly designed for single-use implantation and must be handled under sterile conditions during deployment. The manufacturer’s description emphasizes aseptic techniques, indicating it is not intended for reuse.

What safety considerations should clinicians keep in mind when using this lead in patients who may require MRI scans?

This lead is MRI-safe up to 3 Tesla and classified as Class C, meaning it can be used in patients who need MRI imaging without risk of device malfunction or injury. However, clinicians should confirm compatibility with the specific MRI system and follow manufacturer guidelines to ensure safe imaging procedures.

How is the Model 5013 supplied, and what storage requirements should be followed?

The lead is supplied sterile and pre-packaged for clinical use, ready for immediate implantation. Storage should follow standard sterile medical device protocols—protect from moisture, extreme temperatures, and contamination until use. Check the packaging for expiration dates and any specific storage instructions.

What types of pacemaker systems is this lead compatible with, and does it require any special preparation before use?

The Model 5013 is compatible with standard pacemaker systems as specified by the manufacturer. No additional preparation is required beyond adhering to sterile handling procedures during implantation. Ensure the pacemaker system is programmed correctly post-implantation to match the lead’s specifications.

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: Model 5013 Transvenous Ventricular Pacing Lead - Medtronic Vascular ..., Model 5013 Transvenous Ventricular Pacing Lead, K874792 FDA 510(k) - MODEL 5013 TRANSVENOUS VENTRICULAR PACI..., Medtronic Temporary Sensing and 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) K874792 24 fields · synced Oct 6, 2026