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Unipolar Endocardial Lead DJP 53-UP

FDA 510(k)

Class III (US FDA 510(k))

510(k) K903928

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K903928 FDA 510(k)
FDA Product Code
DTB FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Unipolar Endocardial Lead DJP 53-UP is a permanent pacemaker electrode, classified under product code DTB. This device is designed for endocardial implantation, delivering electrical stimulation to the heart tissue to regulate cardiac rhythm in patients requiring pacemaker therapy.

This lead is supplied sterile and intended for single-use implantation within a cardiac pacemaker system. It is regulated under FDA 510(k) clearance K903928 and falls under Class III device classification. The device is intended for use in cardiac electrophysiology procedures and adheres to the specifications for permanent pacemaker electrodes as defined by regulatory standards.

Frequently asked questions

What is the primary purpose of the Unipolar Endocardial Lead DJP 53-UP in cardiac pacemaker therapy?

The Unipolar Endocardial Lead DJP 53-UP is designed for endocardial implantation to deliver electrical stimulation directly to the heart tissue. Its purpose is to regulate cardiac rhythm in patients who require pacemaker therapy, ensuring proper heart function by providing consistent pacing signals.

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

This lead is intended for single-use only and is supplied sterile, ensuring safety and reliability for one-time implantation within a cardiac pacemaker system. It is not designed for reuse.

What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

The Unipolar Endocardial Lead DJP 53-UP received FDA 510(k) clearance (K903928) under the traditional review pathway, classified as substantially equivalent (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification under product code DTB for permanent pacemaker electrodes.

Does this lead come in multiple sizes or models, and if so, how would a clinician determine the appropriate fit?

The provided data does not specify individual sizes or models beyond the DJP 53-UP designation, but it is categorized as a unipolar endocardial lead, meaning it is designed for specific anatomical placement in the heart. Clinicians would typically select the appropriate lead based on patient anatomy, pacing requirements, and compatibility with the implanted pacemaker system, following standard electrophysiology guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Label Change Unipolar Endocardial Lead Djp 53-up, K903928 - Label Change Unipolar Endocardial Lead Djp 53-up, label change unipolar endocardial lead djp 53-up, PDF K903928 - Label Change Unipolar Endocardial Lead Djp 53-up, K903929 FDA 510(k) - LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, GmbH & Co.

Sources (1)

  • FDA 510(k) K903928 24 fields · synced Sep 18, 2026