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Encor Bipolar Act/Fixa Lead W/Por Sur Ele #329-201

by Cordis Leads, Inc.

510(k) K874366

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874366 Date16 Jun 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Permanent Pacemaker Electrode, designed for cardiac pacing applications. It features a bipolar configuration with a porous surface electrode, enabling precise electrical stimulation of the heart for rhythm regulation in patients requiring permanent pacemaker support.

The Encor Bipolar Act/Fixa Lead is intended for single-use implantation within the cardiovascular system. Supplied sterile, it is classified as a Class III device under FDA regulation 870.3680 and was granted FDA 510K clearance via the traditional pathway in 1988 (K874366). Compatibility with MRI or other imaging modalities is not specified in the available data.

Other devices from Cordis Leads, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Encor Bipolar Act/Fixa Lead, and how does its design support this function?

    The Encor Bipolar Act/Fixa Lead is designed for permanent cardiac pacing, delivering precise electrical stimulation to regulate heart rhythm in patients requiring long-term pacemaker support. Its bipolar configuration ensures focused stimulation, while the porous surface electrode enhances stability and electrical contact with cardiac tissue, improving pacing reliability.

  • Is this lead intended for reuse, or is it meant to be implanted once and discarded?

    This lead is explicitly designed for single-use implantation only, meaning it should not be reused after one procedure. The manufacturer emphasizes its sterile packaging and permanent pacemaker application, which aligns with single-use medical device standards.

  • What regulatory pathway was followed for FDA clearance, and when was the decision made?

    The Encor Bipolar Act/Fixa Lead received FDA 510(k) clearance through the traditional pathway under the Cardiovascular (CV) advisory committee, with a decision of *Substantially Equivalent (SESE)* dated June 16, 1988. The submission was filed on October 23, 1987, and classified as a Class III device under regulation 870.3680.

  • Are there any specific storage requirements mentioned for this lead?

    While the provided data does not detail storage conditions explicitly, the lead is supplied sterile for single-use implantation. Standard sterile medical device storage practices—such as protecting from moisture, extreme temperatures, and physical damage—should be followed to maintain integrity until use.