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510(k) K192211

SoundBite Console, SoundBite Active Wire 18 by Soundbite Medical Solution, Inc. — Product Code PDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
August 14, 2019
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.

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