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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K200439
Device Name Velano ExT Extension Set
Applicant
Velano Vascular
221 Pine St. #200
San Francisco,  CA  94104
Applicant Contact Tiffini Wittwer
Correspondent
Velano Vascular
221 Pine St. #200
San Francisco,  CA  94104
Correspondent Contact Tiffini Wittwer
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/24/2020
Decision Date 02/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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