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Permanent Cardiac Pacing Leads and Adaptors

FDA 510(k)

Class III (US FDA 510(k))

510(k) K912464

by Medtronic Vascular

Identifiers

510(k) Number
K912464 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)

This device is a Permanent Pacemaker Electrode, classified under FDA regulation 870.3680. It consists of pacing leads and adaptors designed to transmit electrical impulses from an implanted pacemaker to the heart muscle, maintaining proper cardiac rhythm in patients with bradyarrhythmias or conduction disorders. The leads are intended for long-term use within cardiac pacing systems, ensuring reliable electrical connectivity and mechanical stability within the heart chambers.

The device is supplied sterile and intended for single-use implantation during surgical procedures. It is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K912464) as substantially equivalent to a predicate device. Adaptors included facilitate compatibility between leads and pacemaker systems, expanding clinical flexibility. Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to use.

Frequently asked questions

Are these pacing leads designed for reuse after a single implantation, or can they be used multiple times in different patients?

These leads are explicitly intended for single-use implantation only. The device description states they are supplied sterile and meant for long-term use within a single patient’s cardiac pacing system. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and reliability.

What types of adaptors are included with these leads, and how do they enhance clinical flexibility?

The device includes adaptors designed to facilitate compatibility between the pacing leads and various pacemaker systems. These adaptors expand clinical flexibility by ensuring proper electrical connectivity and mechanical stability, allowing the leads to integrate seamlessly with different pacemaker models during implantation.

How should these leads be stored before use to maintain their sterility and integrity?

The leads must be stored and handled strictly according to sterile medical device protocols to preserve their integrity. Since they are supplied sterile and intended for single-use, any exposure to non-sterile environments (e.g., improper packaging, contamination) could compromise their safety for implantation.

What specific heart chambers or cardiac conditions are these leads intended to address?

While the device description does not list clinical indications, these leads are designed for long-term use in patients with bradyarrhythmias or conduction disorders requiring permanent cardiac pacing. They are intended to transmit electrical impulses from an implanted pacemaker to the heart muscle, maintaining proper cardiac rhythm in the targeted chambers (e.g., atrium or ventricle).

What is the regulatory pathway for these leads, and how does it relate to their classification?

These leads follow the FDA 510(k) clearance pathway, classified as a Class III medical device under regulation 870.3680. The clearance (K912464) confirms they are substantially equivalent to a predicate device, ensuring they meet stringent safety and performance standards for permanent cardiac pacing applications. The advisory committee involved was the Cardiovascular (CV) Panel.

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: Permanent Cardiac Pacing Leads - Medtronic Vascular | FDA Evidence Review, Pacing Leads and Delivery Systems - Medtronic, Permanent Cardiac Pacing Leads and Adaptors, Medtronis R Pacing Leads and Lead Adaptors - Medtronic Vascular | FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K912464 24 fields · synced Oct 6, 2026