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Rhythmia Mapping Catheter

by Rhythmia Medical, Inc.

510(k) K122461

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122461 Date18 Apr 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0580-2015 FDA Class II initiated 20 Nov 2014

    Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRF
Device Class
Class II
Regulation
21 CFR Part 870.1220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Rhythmia Mapping Catheter is an 8.5 French, 115 cm, bidirectional, 64-electrode, non-linear basket-shaped diagnostic catheter. It features a polymer handle, polymer shaft, and platinum/iridium distal mapping section with an integrated flushing port.

This device is used in cardiac mapping procedures and is supplied as a single-use, sterile product. It is not MRI safe and should be stored according to the manufacturer's instructions. The Rhythmia Mapping Catheter has received FDA 510(k) clearance with the product code DRF and is classified as a Class II device.

Other devices from Rhythmia Medical, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Rhythmia Mapping Catheter used for?

    The Rhythmia Mapping Catheter is designed for use in cardiac mapping procedures. It is an 8.5 French, 115 cm bidirectional catheter with a basket shape containing 64 electrodes, allowing for detailed mapping of cardiac tissue during electrophysiology studies.

  • How is the Rhythmia Mapping Catheter supplied and is it reusable?

    The Rhythmia Mapping Catheter is supplied as a single-use, sterile product. It is not designed for reuse and should be discarded after a single procedure to ensure patient safety and maintain device performance.

  • What are the key specifications of the Rhythmia Mapping Catheter?

    The Rhythmia Mapping Catheter is an 8.5 French, 115 cm device with a bidirectional, basket-shaped design featuring 64 electrodes. It has a polymer handle and shaft, with a platinum/iridium distal mapping section that includes an integrated flushing port.

  • Is the Rhythmia Mapping Catheter MRI safe and how should it be stored?

    The Rhythmia Mapping Catheter is not MRI safe. It should be stored according to the manufacturer's instructions to maintain its integrity and functionality until use.

  • What regulatory status does the Rhythmia Mapping Catheter have?

    The Rhythmia Mapping Catheter has received FDA 510(k) clearance with the product code DRF and is classified as a Class II device. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.