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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 K242276
Device Name CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
Applicant
Vantis Vascular, Inc.
2570 N First St.
Suite 200
San Jose,  CA  95131
Applicant Contact Angela Thompson
Correspondent
Vantis Vascular, Inc.
2570 N First St.
Suite 200
San Jose,  CA  95131
Correspondent Contact Angela Thompson
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/01/2024
Decision Date 09/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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