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Encor Unipolar VS-1 Leads

by Cordis Leads, Inc.

510(k) K883070

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 NumberK883070 Date5 Dec 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  • Withdrawn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, 20 Sep 2026

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

The Encor Unipolar VS-1 Leads are Permanent Pacemaker Electrodes, designed for implantation in the cardiovascular system. These unipolar leads facilitate cardiac pacing by delivering electrical impulses to the heart, supporting rhythm regulation in patients with bradycardia or other conduction disorders. Constructed for long-term use, they are intended to interface with pacemaker systems to ensure consistent and reliable cardiac stimulation.

These leads are supplied sterile and intended for single-use implantation, adhering to FDA-cleared standards under product code DTB. They are classified as Class 3 medical devices, requiring strict regulatory compliance. The device is manufactured by Cordis Leads, Inc., and its specifications align with FDA 510(k) clearance (K883070). Storage and handling must follow sterile medical device protocols to maintain integrity prior to use.

Other devices from Cordis Leads, Inc.

Questions

AI-generated answers, 20 Sep 2026

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

  • Are these leads reusable or intended for single-use only, and how should they be stored to maintain sterility?

    The Encor Unipolar VS-1 Leads are designed for single-use implantation only and are supplied sterile. To preserve sterility before use, they must be stored and handled according to standard sterile medical device protocols, ensuring the packaging remains intact until deployment.

  • What types of pacemaker systems are these leads compatible with, and how are they implanted?

    These unipolar leads are intended to interface with permanent pacemaker systems to deliver electrical impulses for cardiac pacing. They are implanted in the cardiovascular system to support rhythm regulation in patients with bradycardia or conduction disorders, providing long-term, reliable stimulation.

  • What regulatory pathway was followed for FDA clearance, and what classification does this device hold?

    The Encor Unipolar VS-1 Leads were cleared via the FDA 510(k) pathway (K883070) under the Traditional review process, with a decision of *Substantially Equivalent*. They are classified as Class 3 medical devices, requiring strict compliance with regulatory standards for permanent pacemaker electrodes.

  • What product codes or registration numbers identify these leads in regulatory databases?

    These leads are listed under FDA product code DTB (Permanent Pacemaker Electrodes) and include multiple FEI numbers (e.g., 3002618605, 1028232) and registration numbers (e.g., 2017865) in the OpenFDA database. These identifiers help track compliance and submissions.