K250747
- 510(k) number
- K250747
- Device name
- Globe® Pulsed Field System
- Applicant
- Kardium, Inc. CA
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-06-25
- Date received
- 2025-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250747.pdf
Official FDA record: K250747
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.