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TB Series Bipolar Pacing Leads

by Oscor Medical Corp.

510(k) K861403

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK861403 Date27 Jun 1986ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0391-2019 FDA Class I initiated 26 Sep 2018

    During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.

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  • Withdrawn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
LDF
Device Class
Class II
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 TB Series Bipolar Pacing Leads are temporary electrode devices designed for temporary ventricular or atrial pacing when used with a temporary pacemaker. They are available in various curve configurations and French sizes.

These leads are supplied by Oscor Medical Corp. and are classified as a Class II medical device with FDA 510(k) clearance. The device is intended for temporary use and is compatible with Oscor's line of external pacemakers and connection cables.

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Questions

AI-generated answers, 19 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 are the TB Series Bipolar Pacing Leads used for?

    The TB Series Bipolar Pacing Leads are temporary electrode devices designed for temporary ventricular or atrial pacing when used with a temporary pacemaker.

  • What sizes and configurations are available for these leads?

    These leads are available in various curve configurations and French sizes to accommodate different clinical needs.

  • Are these leads single-use or reusable?

    The device is intended for temporary use, but the data does not specify whether they are single-use or reusable.

  • What is the regulatory status of the TB Series Bipolar Pacing Leads?

    The TB Series Bipolar Pacing Leads are classified as a Class II medical device with FDA 510(k) clearance.

  • Which pacemakers are compatible with these leads?

    These leads are compatible with Oscor's line of external pacemakers and connection cables.