360 results
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19ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Avant, Neutrino NxT, Gallant, Entrant, Fortify VR, Fortify DR, Ellipse VR, Ellipse DR, Fortify Assura VR, Fortify A
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·HeartLogic
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·HeartLogic
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR & CELSIUS THERMOCOOL CATHETERS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EZTRK 2, ACUITY SPIRAL, ORIGEN CRT-D, INOGEN CRT-D, DYNAGEN CRT-D, NAV 2 QUADPOLE, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, VI
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
FDA 510(k)
FDA Class 3
·Cardiovascular