DeviceClearance

Kiba CTO Crossing Catheter— 510(k) K262013

Substantially Equivalent

Reflow Medical, Inc.

FDA 510(k) clearance K262013 for Kiba CTO Crossing Catheter, Substantially Equivalent on 2026-08-28. Applicant: Reflow Medical, Inc.. Device class: 2.

Summary

Reflow Medical's Kiba CTO Crossing Catheter is filed under product code PDU, catheters for crossing total occlusions. The record doesn't describe the catheter beyond its name and that code.

Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).

Reflow filed from San Clemente, California. The decision came 74 calendar days after receipt (June 15 to August 28, 2026), and it was substantially equivalent.

Clearance details

Applicant
Reflow Medical, Inc.
Product code
Product code PDU
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Clemente, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PDU

product code PDU
Malfunction
793
Total
793

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.