Kiba CTO Crossing Catheter
FDA 510(k) K262013 · Reflow Medical, Inc.
510(k) numberK262013
Submission
- Device name
- Kiba CTO Crossing Catheter
- Applicant
- Reflow Medical, Inc.
San Clemente, CA, US - Received
- June 15, 2026
- Decision date
- August 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code PDU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252315 | Santreva-ATK Endovascular Revasculariztion CatheterPDU · Traditional | AngioSafe, Inc. | 09/22/2025SE |
| K251158 | PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 09/11/2025SESK |
| K251376 | LimFlow ARCPDU · Special | LimFlow, Inc. | 05/31/2025SE |
| K232562 | PowerWire Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 02/28/2024SESK |
| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 04/25/2023SE |
| K221163 | Tunnel Crossing CatheterPDU · Traditional | Tractus Vascular, LLC | 01/19/2023SE |
| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | Ra Medical Systems,Inc | 06/29/2022SE |
| K211802 | GoBack Crossing CatheterPDU · Traditional | Upstream Peripheral Technologies, Ltd. | 03/01/2022SE |
More from Upstream Peripheral Technologies, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251277 | CoraForce Microcatheter, CoraFlex MicrocatheterDQY · Special | 08/22/2025SE |
| K233350 | SINC Support CatheterDQY · Traditional | 02/08/2024SE |
| K210188 | coraCrossDQY · Special | 05/28/2021SE |
| K201811 | coraForce and coraFlex Support CathetersDQY · Traditional | 10/26/2020SE |
| K200094 | speX LP Support CatheterDQY · Special | 03/18/2020SE |
| K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQY · Traditional | 02/20/2020SE |
| K193012 | speX Support CatheterDQY · Traditional | 02/19/2020SE |
| K190393 | Wingman 14C Crossing CatheterDQY · Special | 05/09/2019SE |
| K173661 | Wingman 35 Crossing CatheterDQY · Traditional | 04/18/2018SE |
| K173662 | speX Support CatheterDQY · Special | 12/20/2017SE |
Questions and answers
When was Kiba CTO Crossing Catheter cleared by the FDA?
Kiba CTO Crossing Catheter (K262013) received a 510(k) decision of Substantially Equivalent on August 28, 2026, 74 days after the submission was received.
What is the product code of K262013?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.