SoundBite Crossing System - Peripheral (14P)
FDA 510(k) K210839 · Soundbite Medical Solutions, Inc.
510(k) numberK210839
Submission
- Device name
- SoundBite Crossing System - Peripheral (14P)
- Applicant
- Soundbite Medical Solutions, Inc.
Montreal, CA - Received
- March 22, 2021
- Decision date
- April 20, 2021
- 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.
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| 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 |
More from Ra Medical Systems,Inc
| 510(k) | Device | Decision |
|---|---|---|
| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | 08/28/2023SE |
Questions and answers
When was SoundBite Crossing System - Peripheral (14P) cleared by the FDA?
SoundBite Crossing System - Peripheral (14P) (K210839) received a 510(k) decision of Substantially Equivalent on April 20, 2021, 29 days after the submission was received.
What is the product code of K210839?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.