510(k) clearance
Kiba CTO Crossing Catheter
- 510(k) number
- K262013
- Applicant
- Reflow Medical, Inc.
- Decision date
- Aug 28, 2026
- Date received
- Jun 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- PDU
- Device type
- Catheter For Crossing Total Occlusions
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- San Clemente, CA, US