Optrell Mapping Catheter with TRUEref Technology
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211438 FDA 510(k)
- FDA Product Code
- MTD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1220 FDA 510(k)
- Regulation Number
- 870.1220 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Optrell Mapping Catheter with TRUEref Technology is a high-density intracardiac mapping catheter designed for electrophysiological studies. It features a fixed array of small electrodes arranged to enable detailed cardiac mapping, facilitating precise localization of arrhythmic activity within heart chambers. This device is classified as a high-density array catheter, optimized for integration with electroanatomical mapping systems to enhance diagnostic accuracy during cardiac procedures.
This catheter is supplied sterile and intended for single-use, deployed through an 8.5 French guiding sheath into a heart chamber. It includes a bi-directionally deflectable tip with six parallel 2 French spines forming three loops, each spine equipped with six platinum electrodes. The device is regulated under FDA 510(k) clearance (K211438) and falls under the medical specialty of cardiovascular diagnostics. Storage and handling must comply with sterile medical device protocols.
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: Biosense Webster Launches the OPTRELL™ Mapping Catheter with TRUEref ..., OPTRELL™ Mapping Catheter with Multipolar Technology, Biosense Webster Launches the OPTRELL™ Mapping Catheter with TRUEref ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211438 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K211438 24 fields · synced Oct 1, 2026