SoundBite® Crossing System XS Peripheral
FDA 510(k) K230159 · Soundbite Medical Solutions, Inc.
510(k) numberK230159
Submission
- Device name
- SoundBite® Crossing System XS Peripheral
- Applicant
- Soundbite Medical Solutions, Inc.
Montreal, CA - Received
- January 19, 2023
- Decision date
- August 28, 2023
- Decision
- Substantially Equivalent (SESE)
- 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.
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|---|---|---|---|
| K262013 | Kiba CTO Crossing CatheterPDU · Special | Reflow Medical, Inc. | 08/28/2026SE |
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| 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 |
| 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 |
|---|---|---|
| K210839 | SoundBite Crossing System - Peripheral (14P)PDU · Special | 04/20/2021SE |
Questions and answers
When was SoundBite® Crossing System XS Peripheral cleared by the FDA?
SoundBite® Crossing System XS Peripheral (K230159) received a 510(k) decision of Substantially Equivalent on August 28, 2023, 221 days after the submission was received.
What is the product code of K230159?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.