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Permanent Pacing Lead Model RXBJ Series

by Oscor Medical Corp.

510(k) K882462

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 NumberK882462 Date28 Oct 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  • Withdrawn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.

The Permanent Pacing Lead Model RXBJ Series is a Permanent Pacemaker Electrode, designed to deliver electrical stimulation to the heart for the management of bradycardia or other cardiac rhythm disorders. These leads are implanted within the cardiac chambers to ensure consistent pacing signals, supporting stable cardiac function in patients requiring long-term cardiac pacing.

This device is supplied sterile and intended for single-use implantation, adhering to Class 3 regulatory standards under FDA 510(k) clearance (K882462). It is classified under product code DTB and manufactured by Oscor Medical Corp., with a decision date of October 28, 1988. The lead is intended for use in clinical settings requiring permanent cardiac pacing solutions, with no additional context regarding MRI safety or reusable components provided in the specifications.

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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.

  • What is the primary purpose of the Permanent Pacing Lead Model RXBJ Series, and how does it function in the body?

    The Permanent Pacing Lead Model RXBJ Series is designed to deliver electrical stimulation directly to the heart’s chambers, helping manage bradycardia or other cardiac rhythm disorders. Implanted permanently, it ensures consistent pacing signals to maintain stable heart function in patients requiring long-term cardiac support.

  • Is this device intended for single-use or reusable applications, and how is it supplied?

    This lead is explicitly intended for single-use implantation only and is supplied sterile, ensuring safety and reliability for one-time surgical use. Reuse is not recommended or supported by the manufacturer.

  • What regulatory pathway was followed for this device, and which advisory committee reviewed it?

    The Permanent Pacing Lead Model RXBJ Series underwent a Traditional 510(k) review under FDA clearance (K882462), classified as a Class 3 device under product code DTB. The Cardiovascular (CV) Advisory Committee reviewed the submission, with a decision date of October 28, 1988.

  • Are there multiple sizes or models within the RXBJ Series, and how would I identify the correct one for a patient?

    The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232) associated with this series, which likely correspond to different lead configurations or sizes (e.g., tip electrode types, coil designs, or fixation mechanisms). While exact sizing details aren’t specified, these identifiers help match the lead to a patient’s anatomy and clinical needs—consult manufacturer documentation or a cardiologist for precise selection.