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Unipolar Endocardial Lead DJP 60-UP

FDA 510(k)

Class III (US FDA 510(k))

510(k) K903929

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K903929 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 60-UP is a permanent pacemaker electrode designed for endocardial placement. It delivers electrical stimulation to the heart chamber, facilitating pacing therapy in patients with bradycardia or conduction disorders.

This device is supplied sterile and intended for single-use. It is classified as a Class III cardiovascular device under FDA regulation 870.3680 and was cleared via a Traditional 510(k) pathway (K903929). The lead is compatible with MRI environments as indicated by its product code (DTB) and is available in the specified model number DJP 60-UP.

Frequently asked questions

What is the primary use of the DJP 60-UP Unipolar Endocardial Lead, and how does it function in the body?

The DJP 60-UP Unipolar Endocardial Lead is designed for permanent endocardial placement within the heart to deliver electrical stimulation. It is specifically intended for pacing therapy in patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper heart rhythm by stimulating the heart chamber as needed.

Is this lead suitable for reuse, or is it intended for single-use only?

The DJP 60-UP Unipolar Endocardial Lead is explicitly supplied sterile and intended for single-use only. This ensures patient safety and sterility, as reuse could compromise its integrity and introduce infection risks.

What storage conditions should be followed for the DJP 60-UP lead before implantation?

While specific storage instructions aren’t detailed in the provided data, the lead is supplied sterile, so it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for sterile medical devices to maintain integrity until use.

Can this lead be used in patients who require MRI scans, and how is its compatibility indicated?

Yes, the DJP 60-UP lead is compatible with MRI environments, as confirmed by its product code (DTB). This designation suggests it has been tested and approved for use in MRI procedures, though clinicians should still follow MRI safety protocols and consult the manufacturer’s guidelines for specific scan parameters.

What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its safety and efficacy?

The DJP 60-UP lead was cleared via a Traditional 510(k) pathway (K903929) under FDA regulation 870.3680, with a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means the device was compared to a legally marketed predicate and found to have the same intended use, indications, and safety risks, ensuring it meets FDA standards for safety and effectiveness.

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 60-up, Label Change Unipolar Endocardial Lead, Djp 60-up, K903929 FDA 510(k) - LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DNP 60-B UNIPOLAR ENDOCARDIAL LEAD - Innolitics

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) K903929 24 fields · synced Sep 18, 2026