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510(k) K211327

Device
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
Applicant
CathRxLtd
510(k) number
K211327
Product code
DRF  
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-10
Date received
2021-05-03
Regulation
870.1220
Classification name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lucy Huang
Address
Unit 8, 2-8 S. St. Rydalmere AU 2116 2116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.2026-01-08
K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.2025-07-23
K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation2025-06-27
K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation2024-11-01
K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation2024-09-06
K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.2023-12-02
K233207Polaris X™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation2023-10-27
K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation2023-09-29
K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific2023-04-25
K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterShanghai Microport EP Medtech Co., Ltd.2022-12-30
K220796IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation2022-06-10
K203793RithmID-SD Steerable Diagnostic Electrophysiology CatheterSynaptic Medical Corporation2022-02-14
K211219LASSOSTAR NAV Circular Mapping CatheterBiosense Webster, Inc.2022-01-26
K212593ViaCath, AcQRate Dx Steerable CatheterBiotronick, Inc.2021-10-15
K211494Polaris X Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation2021-09-14

Legacy Summary#

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FDA Review#

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