Cleared Traditional

Globe? Pulsed Field System

K250747 · Kardium, Inc. · Cardiovascular
Jun 2025
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K250747 is an FDA 510(k) clearance for the Globe? Pulsed Field System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Kardium, Inc. (Burnaby, CA). The FDA issued a Cleared decision on June 25, 2025, 105 days after receiving the submission on March 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K250747 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2025
Decision Date June 25, 2025
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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