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S80 Implantable Cardiac Pacing Lead

by Sorin Biomedica, Fiat, USA, Inc. 510(k)

Active United States

510(k) K854963

Overview

The S80 Implantable Cardiac Pacing Lead is a Permanent Pacemaker Electrode, a class III medical device designed for endocardial placement within the heart. It delivers regulated electrical impulses to maintain proper cardiac rhythm in patients requiring pacing support, typically those with bradycardia or conduction system disorders.

This device is intended for single-use implantation and is supplied sterile. It is regulated under FDA 510(k) clearance (K854963) with a decision of Substantially Equivalent (SESE) under product code DTB and regulation 870.3680. Storage and handling must comply with sterile medical device protocols, and its use is restricted to qualified healthcare professionals in clinical settings.

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 NumberK854963 Date24 Jun 1986ClearedStatusActive

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
  • Withdrawn
  • 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

  • Is the S80 Implantable Cardiac Pacing Lead designed for reuse or single-use, and how should it be handled to maintain sterility?

    The S80 Implantable Cardiac Pacing Lead is explicitly designed for single-use implantation only. Since it is supplied sterile, it must be handled using sterile medical device protocols to preserve its integrity. Reuse is not permitted, and any unused portion must be discarded according to sterile device disposal guidelines.

  • What types of patients is this device intended to support, and how does it function?

    The S80 Implantable Cardiac Pacing Lead is intended for patients with bradycardia or conduction system disorders requiring pacing support. It delivers regulated electrical impulses to the heart’s endocardium, helping maintain a proper cardiac rhythm by stimulating contractions when the natural electrical system is insufficient.

  • How is this device regulated, and which committee reviewed its submission?

    The S80 Implantable Cardiac Pacing Lead is regulated under FDA 510(k) clearance (K854963), classified as a Class III device under product code DTB and regulation 870.3680. Its submission was reviewed by the Cardiovascular (CV) Advisory Committee, with a decision of Substantially Equivalent (SESE) in 1986.

  • Are there multiple sizes or models of this lead, and how would I identify the correct one for a patient?

    The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232), which likely correspond to different batch or lot identifiers rather than distinct sizes or models. The device itself is described as a single design for endocardial placement, so selection should be based on clinician assessment of patient anatomy and pacing requirements rather than size variations. Always verify the specific lot or batch against medical records.