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Biopolar Tined Endocardial Lead 403B/60

by Siemens Elema AB

510(k) K820767

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 NumberK820767 Date9 Apr 1982ClearedStatusActive

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  • Withdrawn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, classified as a bipolar endocardial lead designed for implantation within the heart. It delivers electrical stimulation to regulate cardiac rhythm by positioning electrodes directly against the endocardium, facilitating precise pacing and sensing of cardiac activity.

The Bipolar Tinéd Endocardial Lead 403B/60 is intended for single-use implantation in cardiac pacemaker systems. Supplied sterile and intended for use in clinical settings, it adheres to FDA 510(k) clearance under the Cardiovascular advisory committee. The device is categorized under Device Type DTB and regulated under 21 CFR 870.3680, with a Class III designation. Storage and handling must comply with sterile medical device protocols.

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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.

  • Is this lead designed for reuse in multiple patients, or is it intended for single-use only?

    This lead is explicitly intended for single-use implantation in cardiac pacemaker systems. It is supplied sterile and must not be reused, as per standard sterile medical device protocols for permanent pacemaker electrodes.

  • What storage and handling requirements apply to this device to maintain sterility?

    Since the Bipolar Tinéd Endocardial Lead 403B/60 is supplied sterile, it must be stored and handled according to sterile medical device protocols to preserve its integrity. This includes keeping it in its original packaging until use and avoiding contamination.

  • What regulatory pathway was followed for FDA clearance of this device?

    This lead received FDA 510(k) clearance under the Cardiovascular advisory committee (CV) in 1982, classified as substantially equivalent (SESE) to a predicate device. It falls under 21 CFR 870.3680 with a Class III designation and was reviewed via a traditional 510(k) process.

  • Are there multiple sizes or models available for this lead, or is this a single configuration?

    The provided data does not specify multiple sizes or models for the Bipolar Tinéd Endocardial Lead 403B/60, so it appears to be a single configuration designed for bipolar endocardial pacing. For exact sizing or variations, consult the manufacturer’s documentation.