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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K252315
Device Name Santreva™-ATK Endovascular Revasculariztion Catheter
Applicant
AngioSafe, Inc.
5215 Hellyer Ave., Suite 240
San Jose,  CA  95138
Applicant Contact Rebecca Spelich
Correspondent
AngioSafe, Inc.
5215 Hellyer Ave., Suite 240
San Jose,  CA  95138
Correspondent Contact Rebecca Spelich
Regulation Number870.1250
Classification Product Code
PDU  
Date Received07/25/2025
Decision Date 09/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04663867
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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