PowerWire® 14 Radiofrequency Guidewire Kit
FDA 510(k) K251158 · Baylis Medical Technologies, Inc.
510(k) numberK251158
Submission
- Device name
- PowerWire® 14 Radiofrequency Guidewire Kit
- Applicant
- Baylis Medical Technologies, Inc.
Mississauga, CA - Received
- April 15, 2025
- Decision date
- September 11, 2025
- Decision
- Unknown (SESK)
- Type
- Traditional 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 |
|---|---|---|---|
| K262013 | Kiba CTO Crossing CatheterPDU · Special | Reflow Medical, Inc. | 08/28/2026SE |
| K252315 | Santreva-ATK Endovascular Revasculariztion CatheterPDU · Traditional | AngioSafe, Inc. | 09/22/2025SE |
| 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 |
|---|---|---|
| K254114 | Baylis Connector CableDSA · Special | 01/18/2026SE |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath FootswitchGEI · Traditional | 10/28/2025SE |
| K232562 | PowerWire Radiofrequency Guidewire KitPDU · Traditional | 02/28/2024SESK |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | 05/30/2023SE |
Questions and answers
When was PowerWire® 14 Radiofrequency Guidewire Kit cleared by the FDA?
PowerWire® 14 Radiofrequency Guidewire Kit (K251158) received a 510(k) decision of Unknown on September 11, 2025, 149 days after the submission was received.
What is the product code of K251158?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.