FDA 510(k)

Globe® Pulsed Field System

K-Number: K250747 · 2025-06-25

Decision Date2025-06-25

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Globe® Pulsed Field System is a medical device manufactured by Kardium, Inc.. It received FDA 510(k) clearance on 2025-06-25 under approval number K250747. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Globe® Pulsed Field System?

Globe® Pulsed Field System is a medical device that received FDA 510(k) clearance on 2025-06-25. It is manufactured by Kardium, Inc.. The 510(k) number is K250747.

When was Globe® Pulsed Field System approved by the FDA?

Globe® Pulsed Field System received FDA 510(k) clearance on 2025-06-25, under approval number K250747.

What company makes Globe® Pulsed Field System?

Globe® Pulsed Field System is manufactured by Kardium, Inc..

What is the FDA product code for Globe® Pulsed Field System?

The FDA product code for Globe® Pulsed Field System is DQK.

Related Clinical Trials

NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT07187115 A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07610018 Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems NOT_YET_RECRUITING

Other Devices by Kardium, Inc.

K250529Globe Introducer (601-01001) PMA P240044Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.