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Transvenous Permanent Tined Target Tip Pacing Leads / Transvenous Permanent Screw-In Pacing Leads

FDA 510(k)

Class III (US FDA 510(k))

510(k) K961679

by Medtronic Vascular

Identifiers

510(k) Number
K961679 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
ST FDA 510(k)

This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It consists of transvenous pacing leads designed for permanent implantation, featuring either tined or screw-in fixation mechanisms at the tip to secure the electrode within the heart. These leads are intended for use in cardiac pacing systems to stimulate the heart muscle and maintain proper heart rhythm in patients with bradycardia or conduction disorders.

The leads are supplied sterile and intended for single-use implantation, though they may be used in reusable pacing systems as part of a complete cardiac pacemaker assembly. They are regulated under FDA 510(k) clearance (K961679) and fall under the DTB product code, with specific compliance to regulation number 870.3680. Compatibility with MRI environments is not specified, and storage conditions must adhere to manufacturer guidelines to preserve sterility and functionality.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K961679 24 fields · synced Oct 6, 2026