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510(k) K221163

Tunnel Crossing Catheter by Tractus Vascular, LLC — Product Code PDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2023
Date Received
April 22, 2022
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 Tractus Vascular, LLC

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