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Reflexion HD High-Density Mapping Catheter

by St Jude Medical

510(k) K080179

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 NumberK080179 Date7 Jan 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1291-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010 on shared 510(k) K080179

    Potential for out of specification star grind teeth.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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, 19 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 Reflexion HD High-Density Mapping Catheter is a Catheter, Electrode Recording designed for intracardiac electroanatomical mapping. It features high-density electrode recording capabilities to generate detailed electrical maps and geometries of cardiac tissue, aiding in the identification and treatment of complex arrhythmias.

This catheter is supplied as a reusable, bi-directionally deflectable device with a fixed-radius loop configuration. It includes a ComfortGrip handle with a shaft actuator for distal deflection and an electrical connector. The device is classified as Class II under FDA regulation 870.1220 and holds an FDA 510(k) clearance (K080179) for cardiovascular use. Multiple registration numbers and FEI numbers are associated with its distribution.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Questions

AI-generated answers, 19 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 primary clinical purpose of the Reflexion HD High-Density Mapping Catheter?

    The Reflexion HD High-Density Mapping Catheter is designed specifically for intracardiac electroanatomical mapping. It generates high-resolution electrical maps and 3D geometries of cardiac tissue, which helps clinicians identify and treat complex arrhythmias by providing detailed visualization of electrical activity within the heart.

  • Is the Reflexion HD High-Density Mapping Catheter intended for single-use or reusable applications?

    The Reflexion HD High-Density Mapping Catheter is supplied as a reusable device. It features a bi-directionally deflectable design with a fixed-radius loop configuration, allowing for repeated use in clinical settings while maintaining its functionality for intracardiac mapping.

  • What key features distinguish this catheter from standard mapping catheters?

    This catheter stands out due to its high-density electrode recording capabilities, which enable the creation of detailed and precise electrical maps of cardiac tissue. Additionally, it includes a ComfortGrip handle with a shaft actuator for precise distal deflection, enhancing maneuverability during procedures. The fixed-radius loop configuration further supports accurate mapping in complex cardiac geometries.

  • How is the Reflexion HD High-Density Mapping Catheter regulated in the U.S.?

    The device holds an FDA 510(k) clearance (K080179) under the classification of Class II, regulated under FDA regulation 870.1220. It was determined to be substantially equivalent to a predicate device and was reviewed by the Cardiovascular (CV) Advisory Committee. The clearance confirms its compliance with U.S. regulatory standards for cardiovascular use.

  • What accessories or components are included with the Reflexion HD High-Density Mapping Catheter?

    The catheter comes with a ComfortGrip handle, which includes a shaft actuator for controlling distal deflection, and an electrical connector for data acquisition. These components work together to facilitate precise mapping and ease of use during intracardiac procedures.