Globe Pulsed Field System

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P240044510(k) K250747

by Kardium, Inc.

Identity

Trade Name: Globe® Pulsed Field System FDA PMA
Generic Name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation FDA PMA

Identifiers

PMA Number: P240044 FDA PMA
510(k) Number: K250747 FDA PMA
FDA Product Code: DQK FDA PMA
Models / Variants: Globe® Catheter FDA PMAFDA 510(k)
Globe® Pulsed Field System FDA PMAFDA 510(k)

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 870.1425 FDA PMA
Regulation Number: 870.1425 FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The Globe Pulsed Field System is a percutaneous cardiac ablation catheter designed for the anatomical and electrophysiological mapping and stimulation of cardiac tissue. It is indicated for the delivery of ablation energy to treat drug refractory, recurrent, and symptomatic paroxysmal atrial fibrillation when used in conjunction with the compatible Globe Catheter.

This system is intended for use in clinical settings for catheter-based cardiac procedures. It operates as a specialized medical device for the treatment of cardiac arrhythmias through irreversible electroporation. Users should refer to the specific Instructions for Use provided with the compatible cardiac ablation catheter for detailed procedural guidance and safety information.

Frequently asked questions

What is the primary use of the Globe Pulsed Field System?

The system is primarily used for anatomical and electrophysiological mapping and stimulation of cardiac tissue, as well as for delivering ablation energy to treat symptomatic paroxysmal atrial fibrillation.

Does the Globe Pulsed Field System treat all types of atrial fibrillation?

The device is specifically indicated for the treatment of drug refractory, recurrent, and symptomatic paroxysmal atrial fibrillation when used with the compatible Globe Catheter.

How does the Globe Pulsed Field System function during an ablation procedure?

The system utilizes pulsed field ablation, a method involving irreversible electroporation, to treat cardiac tissue as defined in its regulatory classification as a percutaneous cardiac ablation catheter.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Healthcare Professionals - Kardium, Globe Pulsed Field System for High-definition Mapping ... - PMC, Kardium: Home, Kardium Announces First Commercial Procedures with the ..., Kardium receives FDA OK for pulsed field ablation system

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K250747	Class III	Active
FDA PMA	United States	FDA_PMA	P240044	Class III	Active

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Manufacturer

Manufacturer: Kardium, Inc.

Sources (2)

FDA PMA P240044 36 fields · synced Sep 18, 2026
FDA 510(k) K250747 1 fields · synced May 18, 2026