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Permanent Implantable Jp Endocardial Leads W/Tip

FDA 510(k)

Class III (US FDA 510(k))

510(k) K910609

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K910609 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 Permanent Implantable JP Endocardial Leads with Tip are classified as Permanent Pacemaker Electrodes (product code DTB), a type of Class III medical device. These leads are designed as components of cardiac pacing systems, intended for endocardial placement to facilitate electrical stimulation of the heart.

These leads are supplied sterile and are intended for single-use implantation. They are regulated under FDA 510(k) clearance (K910609) and are intended for use in cardiovascular procedures. The device is manufactured by Biotronik, GmbH & Co., and adheres to regulatory standards for permanent pacemaker electrodes, ensuring compatibility with cardiac pacing systems.

Frequently asked questions

Are these leads reusable or designed for single-use only, and how does that affect their sterility and handling requirements?

These leads are explicitly designed for single-use implantation and are supplied sterile by Biotronik. Because they are not intended for reuse, they must remain unopened until use and be handled with sterile technique to prevent contamination. Discarding after one procedure is critical to maintaining patient safety and compliance with regulatory standards.

What types of cardiac pacing systems are these leads compatible with, and how are they positioned within the heart?

These Permanent Implantable JP Endocardial Leads with Tip are components of cardiac pacing systems and are specifically designed for endocardial placement, meaning they are inserted directly into the heart tissue to deliver electrical stimulation. They are intended for use in permanent pacemaker systems and are compatible with systems that adhere to regulatory standards for pacemaker electrodes.

How are these leads regulated in the U.S., and what does the FDA’s 510(k) clearance (K910609) indicate about their safety and effectiveness?

These leads are regulated under the FDA’s 510(k) clearance process (K910609) as Class III devices, meaning they undergo rigorous review to demonstrate substantial equivalence to a legally marketed predicate device. The clearance indicates that Biotronik has demonstrated that the leads meet the same safety and effectiveness requirements as comparable permanent pacemaker electrodes already on the market, ensuring they are suitable for endocardial pacing applications.

What should clinicians consider when storing these leads before use, given their sterile packaging and single-use nature?

Since these leads are sterile and single-use, they must be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to preserve sterility. Clinicians should also check for expiration dates or damage to the packaging before proceeding with implantation.

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: PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (K910609) — FDA 510(k ..., permanent implantable jp endocardial leads w tip, K910609 FDA 510(k) - PERMANENT IMPLANTABLE JP ENDOCARDIAL LE..., Permanent Implantable Jp Endocardial Leads W/Tip

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) K910609 24 fields · synced Sep 18, 2026