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Model 841 Endocardial Tined Lead

by Pacesetter Systems 510(k)

Active United States

510(k) K812816

Overview

The Model 841 Endocardial Tined Lead is a Permanent Pacemaker Electrode, classified as a Class III device under FDA regulations. It is designed for implantation within the endocardium to deliver electrical impulses to the heart, facilitating proper cardiac rhythm in patients with arrhythmias. The tined structure enhances fixation within the heart tissue, ensuring stable positioning for long-term use.

This device is supplied sterile and intended for single-use implantation during cardiac pacemaker procedures. It is regulated under FDA 510(k) clearance (K812816) and falls under the product code DTB, with a decision classification of Substantially Equivalent to predicate devices. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812816 Date29 Oct 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the Model 841 Endocardial Tined Lead, and how does its design support long-term use in patients?

    The Model 841 Endocardial Tined Lead is designed to deliver electrical impulses to the heart, helping maintain proper cardiac rhythm in patients with arrhythmias. Its tined structure provides enhanced fixation within the endocardium, ensuring stable positioning and reliable function over extended periods, which is critical for permanent pacemaker applications.

  • Is the Model 841 Endocardial Tined Lead intended for reuse, or is it meant for single-use implantation only?

    The Model 841 Endocardial Tined Lead is explicitly supplied sterile and intended for single-use implantation during cardiac pacemaker procedures. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

  • How should the Model 841 Endocardial Tined Lead be stored to ensure it remains suitable for use?

    Since this device is sterile and intended for single-use, storage must follow strict sterile medical device protocols to preserve its integrity. It should be kept in its original packaging, protected from contamination, and stored in a clean, dry environment as directed by the manufacturer’s instructions.

  • What regulatory pathway does the Model 841 Endocardial Tined Lead follow, and how does this affect its availability?

    The Model 841 Endocardial Tined Lead is regulated under the FDA 510(k) clearance process, specifically with clearance number K812816. It is classified as a Class III device and is considered Substantially Equivalent (SESE) to predicate devices, meaning it meets FDA standards for safety and effectiveness. Availability is governed by this regulatory clearance.