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DNP 60-B Unipolar Endocardial Lead

FDA 510(k)

Class III (US FDA 510(k))

510(k) K901709

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K901709 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 DNP 60-B Unipolar Endocardial Lead is a permanent pacemaker electrode, classified as a Class 3 Cardiovascular device. It is designed to transmit electrical impulses from a pacemaker to the heart’s endocardial surface, facilitating pacing and maintaining cardiac rhythm in patients with arrhythmias. The unipolar configuration employs a single electrode for signal delivery, ensuring targeted stimulation within the heart chamber.

This device is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K901709) via the Traditional pathway, with product code DTB. The lead is intended for use in cardiovascular procedures and adheres to regulatory standards for permanent pacemaker electrodes, including MRI safety considerations as defined by its classification. Storage and handling follow sterile medical device protocols.

Frequently asked questions

What is the primary purpose of the DNP 60-B Unipolar Endocardial Lead, and how does its unipolar design benefit patients?

The DNP 60-B Unipolar Endocardial Lead is designed to transmit electrical impulses from a pacemaker to the heart’s endocardial surface, helping to maintain proper cardiac rhythm in patients with arrhythmias. The unipolar configuration uses a single electrode, which allows for targeted stimulation within a specific heart chamber, improving precision in pacing therapy.

Is the DNP 60-B Unipolar Endocardial Lead intended for reuse, or is it meant for single-use only after implantation?

The lead is supplied sterile and explicitly intended for single-use only after surgical implantation. This ensures patient safety and sterility, as reusable leads would risk contamination and compromise clinical outcomes.

What storage and handling guidelines should be followed for the DNP 60-B Unipolar Endocardial Lead to maintain its integrity?

The lead must be stored and handled according to standard sterile medical device protocols. Since it is supplied sterile for single-use, it should remain in its original packaging until immediately before implantation to prevent contamination.

How is the DNP 60-B Unipolar Endocardial Lead regulated in the U.S., and what does its product code (DTB) indicate?

The lead is regulated under the FDA 510(k) clearance pathway (K901709) and classified as a Class 3 Cardiovascular device. The product code DTB categorizes it as a permanent pacemaker electrode, aligning with its intended use in cardiovascular procedures.

Does the DNP 60-B Unipolar Endocardial Lead have any special considerations for MRI compatibility?

While the data does not specify exact MRI safety details, the lead is classified as a permanent pacemaker electrode under FDA regulation 870.3680, which includes MRI safety considerations as part of its design standards. Clinicians should refer to Biotronik’s official documentation for MRI compatibility guidelines before use.

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: dnp 60-b Unipolar Endocardial Lead - Biotronik, Gmbh | FDA Reference, K901709 FDA 510 (k) - DNP 60-B UNIPOLAR ENDOCARDIAL LEAD, DNP 60-B UNIPOLAR ENDOCARDIAL LEAD - Innolitics, K901709 FDA 510 (k) - DNP 60-B 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) K901709 24 fields · synced Sep 18, 2026