FDA.reportPublic FDA data

Cardiac mapping catheter, percutaneous, single-use

Definition
A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.
GUDID devices
928
Last updated
2026-08-28 10:23:50

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05414734216418SJM™ST. JUDE MEDICAL, INC.G4020472016-05-04
08714729270133Polaris X™BOSTON SCIENTIFIC CORPORATIONM0047000D02016-09-24
08714729270140Polaris X™BOSTON SCIENTIFIC CORPORATIONM0047001D02016-09-24
08714729270164Polaris X™BOSTON SCIENTIFIC CORPORATIONM0047003D02016-09-24
08714729270171Polaris X™BOSTON SCIENTIFIC CORPORATIONM0047004D02016-09-24
08714729270188Polaris X™BOSTON SCIENTIFIC CORPORATIONM0047005D02016-09-24
05414734202176Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4015722015-03-05
05414734202312Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4016002015-03-05
05414734202329Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4016032015-03-05
05414734202336Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4016062015-03-05
05414734202350Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4016482015-03-05
05414734202411Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4016542015-03-05
05414734202596Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4019182015-03-05
05414734202633Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4019332015-03-05
05414734202640Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4019342015-03-05
05414734202657Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4019352015-03-05
05414734202701Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4019422023-10-31
05414734202763Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISION4020222015-03-05
08714729082026SteeroCath-Dx™BOSTON SCIENTIFIC CORPORATIONM0042028BL02016-09-24
08714729878797Viking™BOSTON SCIENTIFIC CORPORATIONM004400091P02016-09-24
08714729878803Viking™BOSTON SCIENTIFIC CORPORATIONM004400092P02016-09-24
08714729878810Viking™BOSTON SCIENTIFIC CORPORATIONM004400093P02016-09-24
08714729878827Viking™BOSTON SCIENTIFIC CORPORATIONM004400094P02016-09-24
08714729879831Viking™BOSTON SCIENTIFIC CORPORATIONM0045FVS0008102016-09-24
08714729879961Viking™BOSTON SCIENTIFIC CORPORATIONM0046FVS0039P02016-09-24
08714729900740WovenBOSTON SCIENTIFIC CORPORATIONM00424240102016-09-24
08714729900788WovenBOSTON SCIENTIFIC CORPORATIONM00424240502016-09-24
08714729900856WovenBOSTON SCIENTIFIC CORPORATIONM00424241602016-09-24
08714729900993WovenFlexie™BOSTON SCIENTIFIC CORPORATIONM00450020502016-09-24
00818087022873MAGiC SweepACCESS POINT TECHNOLOGIES, INC.1810012026-05-15
00818087022880MAGiC SweepACCESS POINT TECHNOLOGIES, INC.1810022026-05-15
00818087022897MAGiC SweepACCESS POINT TECHNOLOGIES, INC.1810032026-05-15
00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.1810192026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.1810202026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.1810222026-05-15
00850064686159OptiMap Catheter - 50mmCortex, Inc.OPTI-CATH2-502026-04-02
00850064686166OptiMap Catheter - 60mmCortex, Inc.OPTI-CATH2-602026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.VMRD102-012026-05-06
06952450942581EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.EPD6FD2522024-02-22
06952450942604EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.EPD6FD0102024-02-22
08714729082002SteeroCath-Dx™BOSTON SCIENTIFIC CORPORATIONM0042027BL02016-09-24
08714729877523EP XT™BOSTON SCIENTIFIC CORPORATIONM00420077202016-09-24
08714729877714Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420111202016-09-24
08714729879947EP XT™BOSTON SCIENTIFIC CORPORATIONM0046EPXT003902016-09-24
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHMF00092026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHMF00102026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHMF00112026-01-30
08714729780489Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420SL22202016-09-24
08714729780496Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420SL55502016-09-24
08714729780502Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420SL25202016-09-24
08714729780519Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420SL28202016-09-24
08714729780526Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420SL210202016-09-24
08714729780533Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420SL286002016-09-24
08714729780540Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420SL2202502016-09-24
08714729780557Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420M22202016-09-24
08714729780564Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420M25202016-09-24
08714729780571Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420M2550502016-09-24
08714729780588Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420M2702802016-09-24
08714729780595Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420M540502016-09-24
08714729780601Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420M284002016-09-24
08714729780618Blazer™ Dx-20BOSTON SCIENTIFIC CORPORATIONM00420M2103502016-09-24
00850012226154Multilink CS CatheterCardionxt Inc8210032025-12-10
08714729877479Dynamic Tip™BOSTON SCIENTIFIC CORPORATIONM00420013102016-09-24
08714729877486Dynamic Tip™BOSTON SCIENTIFIC CORPORATIONM00420034402016-09-24
08714729877493EP XT™BOSTON SCIENTIFIC CORPORATIONM00420076902016-09-24
08714729877509EP XT™BOSTON SCIENTIFIC CORPORATIONM00420077002016-09-24
08714729877547EP XT™BOSTON SCIENTIFIC CORPORATIONM00420079402016-09-24
08714729877554EP XT™BOSTON SCIENTIFIC CORPORATIONM00420079502016-09-24
08714729877561EP XT™BOSTON SCIENTIFIC CORPORATIONM00420079602016-09-24
08714729877578EP XT™BOSTON SCIENTIFIC CORPORATIONM00420079702016-09-24
08714729877592EP XT™BOSTON SCIENTIFIC CORPORATIONM00420100702016-09-24
08714729877615Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110102016-09-24
08714729877622Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110202016-09-24
08714729877639Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110302016-09-24
08714729877646Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110402016-09-24
08714729877653Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110502016-09-24
08714729877660Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110602016-09-24
08714729877677Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110702016-09-24
08714729877684Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110802016-09-24
08714729877691Dynamic XT™BOSTON SCIENTIFIC CORPORATIONM00420110902016-09-24