K250410
- 510(k) number
- K250410
- Device name
- GORE® Tri-Lobe Balloon Catheter
- Applicant
- W. L. Gore & Associates, Inc. AZ · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-06-02
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250410.pdf
Official FDA record: K250410
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.