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FDA 510(k)

Globe® Pulsed Field System

K-Number: K250747 · 2025-06-25

ApplicantKardium, Inc.
Decision Date2025-06-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Globe® Pulsed Field System is the device name listed in this FDA 510(k) record. The listed applicant is Kardium, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) 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. The listed applicant is Kardium, Inc.. The 510(k) number is K250747.

When did Globe® Pulsed Field System receive FDA 510(k) clearance?

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

Who is the listed applicant for Globe® Pulsed Field System?

The FDA 510(k) record lists Kardium, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Other records listing Kardium, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240044Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationK250529Globe Introducer (601-01001)

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

Official Source

View on FDA Database →

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

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