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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K262817
Device Name CrossFAST Integrated Microcatheter Advanced Delivery System
Applicant
Vantis Vascular, Inc.
2570 N First St.
Suite 200
San Jose,  CA  95131
Applicant Contact Mai-Ly Wilcox
Correspondent
Vantis Vascular, Inc.
2570 N First St.
Suite 200
San Jose,  CA  95131
Correspondent Contact Mai-Ly Wilcox
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/07/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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