← Back to catalogue

MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP - 60/15-Bp

FDA 510(k)

Class III (US FDA 510(k))

510(k) K010281

by Biotronik, Inc.

Identifiers

510(k) Number
K010281 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
Merox Bipolar High Impedance Lead Models: Mex 53/13-Bp FDA 510(k)
60/15-Bp FDA 510(k)
45-Jbp FDA 510(k)
53-Jbp 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 Merox Bipolar High Impedance Lead is a Permanent Pacemaker Electrode, designed for use in cardiac pacing systems. These leads feature bipolar electrode configurations with high impedance, enabling precise electrical signal delivery for reliable pacing and sensing in patients requiring cardiac rhythm management.

These leads are supplied sterile and intended for single-use implantation within the cardiovascular system. They are classified as Class III medical devices under FDA regulations and have received FDA 510(k) clearance as substantially equivalent to predicate devices. Models include MEX 53/13-BP, 60/15-BP, 45-JBP, and 53-JBP, each tailored for specific pacing applications in accordance with regulatory standards.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K010281 24 fields · synced Oct 6, 2026