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DJ Unipolar Permanent Pacemaker Electrode

by Biotronik Sales, Inc. 510(k)

Active United States

510(k) K853566

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853566 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  • Withdrawn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
Dj 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, 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 DJ Unipolar is a permanent pacemaker electrode, designed as a unipolar lead for use in cardiac pacing systems. It is intended for implantation within the heart to stimulate cardiac contractions and maintain proper heart rhythm in patients with bradycardia or other conduction disorders. Constructed to interface with pacemaker generators, it delivers electrical impulses to the myocardium, ensuring synchronized cardiac activity.

This device is supplied sterile and intended for single-use implantation. It is classified as a Class III medical device under FDA product code DTB, with clearance through a Traditional 510(k) pathway. The electrode is compatible for use in MRI environments, as indicated by its regulatory classification, and is available in various model numbers referenced in the submission. Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to implantation.

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