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ELOX 45-BP - Model 331 549

FDA 510(k)

Class III (US FDA 510(k))

510(k) K001413

by Biotronik, Inc.

Identifiers

510(k) Number
K001413 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
330 132 FDA 510(k)
Efh-27 FDA 510(k)
Model 331 549 FDA 510(k)
Extension Tool FDA 510(k)
Model 331 668 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 Extension Tool, designed to facilitate the connection and extension of pacemaker leads during cardiovascular procedures. It ensures proper alignment and secure attachment of electrodes to pacemaker systems, supporting reliable pacing therapy delivery in patients requiring cardiac rhythm management.

The Elox Extension Tools are reusable, single-use accessories intended for use in sterile environments such as cardiac catheterization labs or operating rooms. Each model (330 132, EFH-27, 331 549, and 331 668) is classified as a Class III device under FDA regulations, with clearance granted under FDA 510K (K001413). They comply with 21 CFR 870.3680 and are tracked for post-market surveillance as part of permanent pacemaker electrode systems.

Frequently asked questions

What is the primary purpose of the ELOX 45-BP Extension Tools in a clinical setting?

The ELOX 45-BP Extension Tools (models 330 132, EFH-27, 331 549, and 331 668) are designed to assist in connecting and extending pacemaker leads during cardiovascular procedures. They ensure proper alignment and secure attachment of electrodes to pacemaker systems, which is critical for delivering reliable pacing therapy to patients requiring cardiac rhythm management.

Are these extension tools intended for single-use or reusable applications?

These tools are explicitly labeled as reusable but are intended for single-use per sterile procedure—such as in cardiac catheterization labs or operating rooms—to maintain sterility and prevent cross-contamination between patients.

How are these tools regulated, and what does the FDA classification imply?

The ELOX 45-BP Extension Tools are classified as Class III devices under FDA regulations, with clearance granted via 510(k) (K001413). This classification reflects their role in permanent pacemaker electrode systems, which are high-risk medical devices requiring stringent oversight. The tools are also subject to tracking as part of post-market surveillance, ensuring compliance with 21 CFR 870.3680.

What models are included in the ELOX 45-BP series, and how might they differ?

The series includes four models: 330 132, EFH-27, 331 549, and 331 668. While the exact functional differences between them aren’t detailed in the data, they are all designed for the same core purpose—facilitating lead extension and electrode attachment. Clinicians should refer to manufacturer documentation for model-specific compatibility with pacemaker systems or lead types.

Where should these tools be stored, and are there any special handling requirements?

Since these tools are reusable but single-use per procedure, they must be stored in a clean, dry environment to prevent contamination. After use, they should undergo proper cleaning and sterilization (if reusable) before storage. The manufacturer’s instructions should be followed to ensure they remain functional and compliant for future sterile procedures.

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) K001413 24 fields · synced Sep 18, 2026