K262013
- 510(k) number
- K262013
- Device name
- Kiba CTO Crossing Catheter
- Applicant
- Reflow Medical, Inc. CA · US
- Product code
- PDU — Catheter For Crossing Total Occlusions
- Decision date
- 2026-08-28
- Date received
- 2026-06-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K262013.pdf
Official FDA record: K262013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.