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FDA 510(k)

Globe Introducer (601-01001)

K-Number: K250529 · 2025-06-03

ApplicantKardium, Inc.
Decision Date2025-06-03
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Globe Introducer (601-01001) is the device name listed in this FDA 510(k) record. The listed applicant is Kardium, Inc.. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K250529. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Globe Introducer (601-01001)?

Globe Introducer (601-01001) is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Kardium, Inc.. The 510(k) number is K250529.

When did Globe Introducer (601-01001) receive FDA 510(k) clearance?

Globe Introducer (601-01001) received FDA 510(k) clearance on 2025-06-03, under 510(k) number K250529.

Who is the listed applicant for Globe Introducer (601-01001)?

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 Introducer (601-01001)?

The FDA product code for Globe Introducer (601-01001) is DRA.

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 ElectroporationK250747Globe® Pulsed Field System

Related Devices (Code: DRA)

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.

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific CorporationK233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICALK221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.

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.

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