510(k) K262013
K262013 is an FDA 510(k) premarket notification submitted by Reflow Medical, Inc. for the device "Kiba CTO Crossing Catheter". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code PDU (Catheter For Crossing Total Occlusions), a Class II device regulated under 21 CFR 870.1250. Reflow Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2026
- Date Received
- June 15, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter For Crossing Total Occlusions
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.