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DJP Unipolar Permanent Pacemaker Electrode

by Biotronik Sales, Inc. 510(k)

Active United States

510(k) K853567

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853567 Date7 May 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Djp Unipolar
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 DJP Unipolar is a Permanent Pacemaker Electrode, designed for implantation in the heart to deliver electrical stimulation for cardiac pacing. It facilitates unipolar pacing, ensuring consistent and reliable cardiac rhythm support in patients requiring long-term pacing therapy.

This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings. It is classified under FDA product code DTB and has received FDA 510(k) clearance (K853567) as a Class III medical device. The electrode is compatible with Biotronik’s pacemaker systems and adheres to regulatory standards for permanent cardiac pacing applications.

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