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Khelix Steerable Electrophysiology Catheters

by CathRx, Ltd. EUDAMED510(k)

Active European Union and United States

510(k) K211327Ref SC1-B2515U-10P7888Model Diagnostic Electrophysiology Catheter

Overview

The Khelix Steerable Electrophysiology Catheters are classified as Catheter, Electrode Recording, or Probe, Electrode Recording. These devices are designed for use in electrophysiology procedures to map and ablate cardiac arrhythmias by delivering precise electrical stimulation and recording electrical activity within the heart. Their steerable and loop configurations enable targeted access to complex cardiac structures, improving accuracy and procedural outcomes.

These catheters are supplied sterile and intended for single-use. They are classified under the FDA’s Device Class 2 and are authorized via FDA 510(k) clearance and the EU’s Medical Device Directive (MDD). The devices are engineered for use in electrophysiology labs and cardiac catheterization suites, with various loop sizes and steerable designs to accommodate different anatomical and procedural requirements. Compliance with MRI safety standards is not specified, and storage conditions should follow manufacturer guidelines for sterile, single-use medical devices.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-09351351000104 Basic UDI-DIDate29 Jan 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211327 Date10 Feb 2022ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

Full name
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
Trade Name
Khelix
Device Name
Khelix Decapolar Variable Loop Steerable Electrophysiology Catheter
Model / Reference
Diagnostic Electrophysiology Catheter, SC1-B2515U-10P7888
Primary DI / UDI-DI
09351351000104
Basic UDI-DI
B-09351351000104
510(k) Number
FDA Product Code
DRF
EMDN Code
C02010403 Arrhythmology multipolar diagnostic catheters, adjustable
Device Class
Class III EUDAMED
Class II 510(k)
Regulation
21 CFR Part 870.1220
Market of Registration
Germany
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class III
510(k)
Class II

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Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No