FDA 510(k)

Globe Introducer (601-01001)

K-Number: K250529 · 2025-06-03

Decision Date2025-06-03

Product CodeDRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Globe Introducer (601-01001) is a medical device manufactured by Kardium, Inc.. It received FDA 510(k) clearance on 2025-06-03 under approval 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. It is manufactured by Kardium, Inc.. The 510(k) number is K250529.

When was Globe Introducer (601-01001) approved by the FDA?

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

What company makes Globe Introducer (601-01001)?

Globe Introducer (601-01001) is manufactured by Kardium, Inc..

What is the FDA product code for Globe Introducer (601-01001)?

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

Other Devices by Kardium, Inc.

K250747Globe® Pulsed Field System PMA P240044Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

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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.