Cleared Special

K262013 - Kiba CTO Crossing Catheter

K262013 is an FDA 510(k) clearance for Kiba CTO Crossing Catheter, manufactured by Reflow Medical, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Special 510(k) pathway after a 74-day FDA review.

K262013 · Reflow Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
74d
Days
Class 2
Risk

K262013 is an FDA 510(k) clearance for the Kiba CTO Crossing Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Reflow Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 28, 2026 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262013

510(k) Number K262013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2026
Decision Date August 28, 2026
Days to Decision 74 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

PDU Device Classification - Class 2, Special Controls

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 57
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K262013.
Santreva™-ATK Endovascular Revasculariztion Catheter
K252315 · AngioSafe, Inc. · Sep 2025
PowerWire® 14 Radiofrequency Guidewire Kit
K251158 · Baylis Medical Technologies, Inc. · Sep 2025
LimFlow ARC
K251376 · LimFlow, Inc. · May 2025
PowerWire Radiofrequency Guidewire Kit
K232562 · Baylis Medical Technologies, Inc. · Feb 2024
SoundBite® Crossing System XS Peripheral
K230159 · Soundbite Medical Solutions, Inc. · Aug 2023
Tigereye ST CTO-Crossing Catheter
K230594 · Avinger, Inc. · Apr 2023
K262013 · Kiba CTO Crossing Catheter
Download PDF FDA Summary Reflow Medical, Inc.