510(k) K252315

Santreva-ATK Endovascular Revasculariztion Catheter by AngioSafe, Inc. — Product Code PDU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 22, 2025
Date Received: July 25, 2025
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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