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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K163508
Device Name PIVO
Applicant
Velano Vascular
1756 Fillmore St.
San Francisco,  CA  94115
Applicant Contact Tiffini Diage
Correspondent
Velano Vascular
1756 Fillmore St.
San Francisco,  CA  94115
Correspondent Contact Tiffini Diage
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/14/2016
Decision Date 02/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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