Kiba CTO Crossing Catheter— 510(k) K262013

Name: FDA 510(k) clearance K262013
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

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.

Clearance details

Applicant: Reflow Medical, Inc.
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2026-06-15
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDU

view all

K252315 — Santreva-ATK Endovascular Revasculariztion Catheter2025-09-22
K251158 — PowerWire® 14 Radiofrequency Guidewire Kit2025-09-11
K251376 — LimFlow ARC2025-05-31
K232562 — PowerWire Radiofrequency Guidewire Kit2024-02-28
K230159 — SoundBite® Crossing System XS Peripheral2023-08-28

More clearances from Reflow Medical, Inc.

view all

K251277 — CoraForce Microcatheter, CoraFlex Microcatheter2025-08-22
DEN240048 — Spur Peripheral Retrievable Stent System2025-05-29
K233350 — SINC Support Catheter2024-02-08
K201811 — coraForce and coraFlex Support Catheters2020-10-26
K190393 — Wingman 14C Crossing Catheter2019-05-09

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.