FDA.reportPublic FDA data

Cardiac radio-frequency ablation system generator

Definition
An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.
GUDID devices
64
Last updated
2026-08-28 10:31:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05415067054661TactiSys™ST. JUDE MEDICAL, INC.TSQ-V1.8-TFDM-012026-08-19
10840143912832Cannula with GuideATRICURE, INC.CSK-61312026-05-31
30840143913703Multifunctional Ablation GeneratorATRICURE, INC.MAG2026-05-27
10840143900280Subtle Cannula with Guide ATRICURE, INC.CSK-61302021-01-08
10840143900303Subtle Cannula with Guide ATRICURE, INC.CSK-61402021-01-08
10840143900327EPi-Sense Guided Coagulation System with VisiTraxATRICURE, INC.CDK-14132021-01-08
10840143900341EPi-Sense Guided Coagulation System with VisiTraxATRICURE, INC.CSK-20002021-01-08
10840143900402Isolator Surgical Ablation SystemATRICURE, INC.EMT12021-01-08
10840143901454nContact RF GeneratorATRICURE, INC.CSK-3202021-01-11
10840143901485Coagulation RF cableATRICURE, INC.CSK-20602022-09-23
10840143901980Isolator Surgical Ablation SystemATRICURE, INC.MAX12021-01-08
10840143902109Synergy™ Ablation SystemATRICURE, INC.OLL22021-01-08
10840143902161Isolator Surgical Ablation SystemATRICURE, INC.EMR22021-01-11
10840143902192Synergy™ Ablation SystemATRICURE, INC.OSL22021-01-08
10840143902222Isolator Surgical Ablation SystemATRICURE, INC.EML22021-01-11
10840143902253Isolator Surgical Ablation SystemATRICURE, INC.MCR12021-01-11
10840143902260Isolator Surgical Ablation SystemATRICURE, INC.MAX52021-01-08
10840143902574Isolator Surgical Ablation SystemATRICURE, INC.MLP12021-01-11
10840143904134AtriCure Isolator Synergy EnCompass Clamp and GuideSystemATRICURE, INC.GPM1002021-08-12
10840143904530Coagulation RF CableATRICURE, INC.CSK-20002021-05-24
10840143904547Subtle Cannula with Guide ATRICURE, INC.CSK-61302021-05-24
10840143904578nContact RF GeneratorATRICURE, INC.CSK-3202021-05-24
10840143904585EPi-Sense ST Coagulation Device ATRICURE, INC.EPiST2022-09-23
10840143905193AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OLH2023-01-04
10840143905995AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OSH2023-02-07
10840143907807EPi-Sense Guided Coagulation SystemATRICURE, INC.CDK-14132026-04-23
10840143907852Cannula with GuideATRICURE, INC.CSK-61312026-04-23
10840143909375EPi-Sense Guided Coagulation SystemATRICURE, INC.CSK-20002026-04-23
10840143909382EPi-Sense ST Guided Coagulation SystemATRICURE, INC.CSK-20602026-04-23
10840143913273EPi-Sense STATRICURE, INC.EPiST2026-04-23
10840143913761Isolator Synergy™ ATRICURE, INC.OSL22026-05-12
10840143913884EPi-Sense STATRICURE, INC.EPiST2026-04-23
30840143902950Isolator Surgical Ablation SystemATRICURE, INC.ASU22026-02-06
30840143904473Multifunctional Ablation GeneratorATRICURE, INC.MAG2023-02-21
10840143901553Isolator Surgical Ablation SystemATRICURE, INC.ASU22026-02-06
00199150027521Cardioblate™MEDTRONIC, INC.493212026-01-16
00199150027538Cardioblate™MEDTRONIC, INC.493412026-01-16
00199150027569Cardioblate™MEDTRONIC, INC.608312026-01-16
00199150027576Cardioblate®MEDTRONIC, INC.608412026-01-16
10846835017472nGEN PumpBiosense Webster IncD1397022022-06-09
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.AFR-000042025-08-30
00763000841607Cardioblate™ Gemini™-sMEDTRONIC, INC.493512025-05-18
05415067046734Ampere™ST. JUDE MEDICAL, INC.H700488-CQM2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.H700494-CQM2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.H700490-CQM2025-01-14
00763000708917DiamondTemp™ FASTR RF GeneratorMEDTRONIC, INC.CEDTG2002024-12-14
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.AFR-000042024-11-04
04260166374063INTELLAGEN™ RF GeneratorStockert GmbH204042024-09-01
04260166374070INTELLAGEN™ RF Generator KitStockert GmbH204012024-09-01
04260166374094INTELLAGEN™ Remote Control KitStockert GmbH204032024-09-01
04260166374100INTELLAGEN™ Remote ControlStockert GmbH204062024-09-01
00763000841591Cardioblate™ Gemini™-sMEDTRONIC, INC.492602024-04-28
00763000745516DiamondTemp™ FASTR RF GeneratorMEDTRONIC, INC.CEDTG2002023-08-13
00763000687960DiamondTemp™ FASTR RF GeneratorMEDTRONIC, INC.CEDTG2002023-05-13
10840143900044Multifunctional Ablation GeneratorATRICURE, INC.MAG2023-02-21
10840143905834AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OLH2023-02-07
30840143904817AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OSH2023-02-07
10840143905209AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OSH2023-01-04
10840143905520AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.GPM1002023-01-04
30840143904114AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OLH2023-01-04
10840143901607Cannula with GuideATRICURE, INC.CSK-61312022-09-23
30840143901656EPi-Sense ST Coagulation Device ATRICURE, INC.EPiST2022-09-23
30840143901663Coagulation RF cableATRICURE, INC.CSK-20602022-09-23
10846835018080nGEN GeneratorBiosense Webster IncD1384022022-08-18