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TIR/TIJ and Polyrox Permanent Pacemaker Electrode

FDA 510(k)

Class III (US FDA 510(k))

510(k) K972500

by Biotronik, Inc.

Identifiers

510(k) Number
K972500 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
PT FDA 510(k)

The TIR/TIJ and Polyrox Permanent Pacemaker Electrode is a Permanent Pacemaker Electrode (Device Type: DTB, Regulation Number: 870.3680), designed for implantation in the cardiovascular system. It provides pacing and sensing capabilities for patients requiring cardiac rhythm management, with leads intended for use in the right atrium (TIR) and right ventricle (TIJ) positions. The electrode features a Polyrox coating to enhance biocompatibility and reduce tissue reaction over time.

This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings such as cardiac catheterization labs or operating rooms. It is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K972500) as substantially equivalent with tracking and post-market surveillance requirements. Various model numbers (e.g., 3002618605, 1028232) correspond to specific lead configurations, and proper storage adheres to manufacturer guidelines for sterile packaging integrity.

Frequently asked questions

What types of pacing and sensing capabilities does the TIR/TIJ and Polyrox Permanent Pacemaker Electrode provide, and where is it implanted?

The TIR/TIJ and Polyrox Permanent Pacemaker Electrode is designed for dual-chamber pacing and sensing, with leads intended for implantation in the right atrium (TIR) and right ventricle (TIJ). This configuration supports cardiac rhythm management for patients requiring synchronized atrial and ventricular pacing, reducing the risk of irregular heartbeats.

Is this device intended for reuse, or is it meant for single-use only? How should it be handled to maintain sterility?

This device is sterile and intended for single-use only. It must remain in its original, unopened sterile packaging until immediately before implantation by qualified healthcare professionals. The packaging integrity must be verified prior to use to ensure sterility is preserved.

What model numbers are associated with the TIR/TIJ and Polyrox Permanent Pacemaker Electrode, and how do they relate to lead configurations?

The device comes in multiple model numbers, including 3002618605, 1028232, 3008377825, and others listed in the data. These correspond to specific lead configurations for right atrial (TIR) and right ventricular (TIJ) implantation. The manufacturer’s guidelines should be consulted to confirm compatibility with your clinical needs.

How is the Polyrox coating on this electrode beneficial for patients, and does it affect long-term use?

The Polyrox coating enhances biocompatibility and reduces tissue reaction over time, minimizing inflammation or fibrosis around the implanted lead. This helps maintain stable pacing and sensing performance for patients requiring long-term cardiac rhythm management.

What regulatory pathway was followed for FDA clearance, and what ongoing requirements apply to this device?

The TIR/TIJ and Polyrox Permanent Pacemaker Electrode received FDA 510(k) clearance (K972500) under the Traditional pathway, with a decision of Substantially Equivalent (PT). It is classified as a Class III device and is subject to tracking and post-market surveillance (PMS) requirements to ensure continued safety and performance.

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) K972500 24 fields · synced Sep 18, 2026