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Ex 45-Bp, Model 330 132 +2 more models

FDA 510(k)

Class III (US FDA 510(k))

510(k) K994240

by Biotronik, Inc.

Identifiers

510(k) Number
K994240 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
Ex 45-Bp, Model 330 132 FDA 510(k)
Ex 53-Bp, Model 130 018 FDA 510(k)
Ex 60-Bp, Model 330 133 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
ST FDA 510(k)

This device is a Permanent Pacemaker Electrode, designed for implantation within the cardiovascular system to provide electrical stimulation to the heart. It facilitates pacing therapy for patients with bradycardia or other cardiac conduction disorders by delivering timed electrical impulses to regulate heart rhythm.

The electrodes are supplied sterile and intended for single-use implantation. They are classified as Class III devices under FDA regulations and are subject to traditional 510(k) clearance. Each model (EX 45-BP, EX 53-BP, EX 60-BP) corresponds to specific electrode configurations, with model numbers and reference codes preserved for identification. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

Are these pacemaker electrodes reusable or intended for single-use only, and how should they be stored to maintain sterility?

These electrodes (EX 45-BP, EX 53-BP, EX 60-BP) are explicitly designed for single-use implantation only and are supplied sterile. To preserve sterility, they must be stored and handled according to standard sterile medical device protocols, as outlined in the manufacturer’s instructions.

What are the key differences between the EX 45-BP, EX 53-BP, and EX 60-BP models, and how do I select the right one for a patient?

Each model corresponds to a specific electrode configuration for pacing therapy, but the exact clinical distinctions (e.g., lead length, tip design, or pacing capabilities) are not detailed in the provided data. Selection should be based on the patient’s anatomical needs and the implanting physician’s preference, guided by Biotronik’s clinical guidelines or technical documentation.

How do I verify the regulatory status of these electrodes before use, and where can I find additional information?

These electrodes hold FDA 510(k) clearance (K994240) under the traditional pathway, classified as Class III devices. For full regulatory details, including compliance history, refer to the FDA’s OpenFDA database using the listed FEI numbers or consult Biotronik’s official documentation. The submission was reviewed by the Cardiovascular (CV) Advisory Committee in 2000.

Are there any specific handling or preparation steps required before implantation to ensure proper function?

While the data does not specify pre-implantation preparation steps beyond standard sterile handling, these electrodes are sterile upon packaging and intended for direct implantation. Always follow Biotronik’s instructions for use (IFU) and local sterile technique protocols to avoid contamination or damage 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K994240 24 fields · synced Oct 6, 2026