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PS-Endocardial Leads

FDA 510(k)

Class III (US FDA 510(k))

510(k) K896824

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K896824 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 PS-Endocardial Leads are classified as Permanent Pacemaker Electrodes, designed for endocardial pacing applications. These leads are intended for implantation within the heart to deliver electrical stimulation for cardiac rhythm management, ensuring proper heart function in patients requiring pacing therapy.

These leads are supplied sterile and are intended for single-use. They are regulated under FDA 510(k) clearance (K896824) and fall under the DTB product code, classified as a Class 3 medical device. The device is intended for use in cardiovascular procedures and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

Are these leads reusable or designed for single-use only, and what does that mean for my clinical workflow?

The PS-Endocardial Leads are explicitly designed for single-use only, meaning they must not be reused after implantation. This ensures sterility and safety for patients. Clinically, this means each lead is intended for one patient, reducing infection risks and simplifying inventory management—you’ll need to order replacements for each procedure rather than sterilizing or reprocessing them.

How should I store these leads to maintain their sterility and functionality before use?

The leads are supplied sterile, so storage must follow Biotronik’s guidelines to preserve sterility and integrity. They should be kept in their original packaging, protected from moisture, extreme temperatures, and direct sunlight. Avoid exposing them to contaminants or rough handling, as this could compromise their performance or sterility before implantation.

What sizes or models of these leads are available, and how do I determine the right fit for a patient?

The PS-Endocardial Leads come in multiple FEI (Femoral Endovascular Implantation) numbers, which correspond to different lead sizes and configurations (e.g., 3002618605, 3008377825). The correct size depends on the patient’s anatomy, pacing needs, and the implantation site (e.g., right ventricle or atrium). Consult Biotronik’s product catalog or clinical guidelines to match the FEI number to the patient’s specific requirements, as improper sizing may affect pacing performance or comfort.

What regulatory pathway does this device follow, and how does that affect my purchasing or use?

These leads are classified as Class 3 medical devices under FDA regulations and were cleared via a Traditional 510(k) pathway (K896824) with a decision of *Substantially Equivalent* to a predicate device. This means they undergo rigorous review for safety and effectiveness in cardiovascular applications. Clinically, this clearance confirms their compliance with FDA standards for permanent pacemaker electrodes, but it does not imply any specific indication—only that they meet regulatory requirements for endocardial pacing.

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: Biotronik S PS-Endocardial Leads - Biotronik, Gmbh & | FDA Evidence Review, K896824 FDA 510(k) - BIOTRONIK'S PS-ENDOCARDIAL LEADS, BIOTRONIK'S PS-ENDOCARDIAL LEADS (K896824) - Innolitics, Biotronik's Ps-endocardial Leads 510 (k) FDA Premarket Notification ..., Pamira - Biotronik

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) K896824 24 fields · synced Sep 18, 2026