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Kardium, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories3
Latest FDA decision2026-06-23
TypeNumberDevice NameCodeDateActions
PMA P240044 Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationQZI2026-06-23 View
510(k) K250747 Globe® Pulsed Field SystemDQK2025-06-25 View
510(k) K250529 Globe Introducer (601-01001)DRA2025-06-03 View

Related Clinical Trials

NCT07651852Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial FibrillationNOT_YET_RECRUITINGNCT07714876Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial FibrillationNOT_YET_RECRUITING
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