K254040
- 510(k) number
- K254040
- Device name
- LungFlow Basket Catheter
- Applicant
- Free Flow Medical, Inc. CA · US
- Product code
- KTI — Bronchoscope Accessory
- Decision date
- 2026-03-12
- Date received
- 2025-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254040.pdf
Official FDA record: K254040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.