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Unipolar Endocardial Lead, DJP 45-UP

FDA 510(k)

Class III (US FDA 510(k))

510(k) K903927

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K903927 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 45-UP, is a permanent pacemaker electrode designed for endocardial implantation. It is intended for use in cardiac pacing applications, delivering electrical stimulation to the heart’s inner lining to regulate rhythm and conduction.

This lead is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under the traditional review pathway. It is classified as a Class III device under the regulation number 870.3680, with advisory committee oversight from the Cardiovascular panel. The device is intended for use in cardiac electrophysiology settings and must be handled and stored according to manufacturer guidelines.

Frequently asked questions

What is the primary purpose of the Unipolar Endocardial Lead, DJP 45-UP, and where is it used in the body?

The Unipolar Endocardial Lead, DJP 45-UP, is designed specifically for endocardial implantation, meaning it is placed inside the heart’s inner lining to deliver electrical stimulation. It is intended for cardiac pacing applications, helping regulate heart rhythm and conduction in patients who require pacing support.

Is this lead reusable, or is it meant for single-use only? How should it be stored?

This lead is intended for single-use only and is supplied sterile. To maintain sterility and functionality, it must be handled and stored strictly according to manufacturer guidelines, which likely include keeping it in its original packaging until use.

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

The Unipolar Endocardial Lead, DJP 45-UP, received FDA 510(k) clearance under the traditional review pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. The Cardiovascular (CV) advisory committee provided oversight during the review process.

What type of medical specialty is this lead intended for, and where would it typically be used?

This lead is classified under Cardiovascular medical specialty and is intended for use in cardiac electrophysiology settings. It would typically be deployed in clinical environments like hospitals or specialized cardiac centers where pacemaker implantation and rhythm management procedures are performed.

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.

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) K903927 24 fields · synced Sep 18, 2026