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510(k) K230159

SoundBite® Crossing System XS Peripheral by Soundbite Medical Solutions, Inc. — Product Code PDU

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.

Other clearances by Soundbite Medical Solutions, Inc.

  • K210839 — SoundBite Crossing System - Peripheral (14P) (April 20, 2021)

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