K250529
- 510(k) number
- K250529
- Device name
- Globe Introducer (601-01001)
- Applicant
- Kardium, Inc. CA
- Product code
- DRA — Catheter, Steerable
- Decision date
- 2025-06-03
- Date received
- 2025-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250529.pdf
Official FDA record: K250529
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.