DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording Class II

FDA Device Classification

Classification Details

Product Code
DRF
Device Class
Class II
Regulation Number
870.1220
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252794imricor medical systemsVision-MR™ Diagnostic CatheterJanuary 8, 2026
K250590stereotaxisMAGiC Sweep™ EP Mapping CatheterJuly 23, 2025
K250310boston scientific corporationVIKING™ Fixed Curve Diagnostic CatheterJune 27, 2025
K240366boston scientific corporationEP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ UnidirectionalNovember 1, 2024
K233900synaptic medical corporationNordica PV Cryo Mapping CatheterSeptember 6, 2024
K233397medtronicCosine-10TM Diagnostic CatheterDecember 2, 2023
K233207boston scientific corporationPolaris X™ Unidirectional Steerable Diagnostic CatheterOctober 27, 2023
K232651boston scientific corporationBLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterSeptember 29, 2023
K230503boston scientificPolaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableApril 25, 2023
K210313shanghai microport ep medtech coEasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDecember 30, 2022
K220796boston scientific corporationIntellaMap Orion High Resolution Mapping CatheterJune 10, 2022
K203793synaptic medical corporationRithmID-SD Steerable Diagnostic Electrophysiology CatheterFebruary 14, 2022
K211327cathrxKhelix Steerable Electrophysiology Catheters, Khelix Loop Fixed ElectrophysiologFebruary 10, 2022
K211219biosense websterLASSOSTAR NAV Circular Mapping CatheterJanuary 26, 2022
K212593biotronickViaCath, AcQRate Dx Steerable CatheterOctober 15, 2021
K211494boston scientific corporationPolaris X Unidirectional Steerable Diagnostic CatheterSeptember 14, 2021
K211375boston scientific corporationBlazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterSeptember 10, 2021
K201445biotronikMultiCath, AcQRate Dx Fixed Curve CatheterSeptember 2, 2021
K203261innovative healthReprocessed Inquiry Steerable Diagnostic EP CatheterMarch 5, 2021
K193632biosense websterLassoStar Circular Mapping CatheterJune 30, 2020