510(k) K230159
K230159 is an FDA 510(k) premarket notification submitted by Soundbite Medical Solutions, Inc. for the device "SoundBite® Crossing System XS Peripheral". The FDA issued a decision of Substantially Equivalent on August 28, 2023. The device falls under product code PDU (Catheter For Crossing Total Occlusions), a Class II device regulated under 21 CFR 870.1250. Soundbite Medical Solutions, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2023
- Date Received
- January 19, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter For Crossing Total Occlusions
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
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.