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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 K152924
Device Name TIVA¿
Applicant
Velano Vascular
4040 Locust St.
Philadelphia,  PA  19104
Applicant Contact TIFFINI DIAGE
Correspondent
Velano Vascular
4040 Locust St.
Philadelphia,  PA  19104
Correspondent Contact TIFFINI DIAGE
Regulation Number862.1675
Classification Product Code
JKA  
Date Received10/05/2015
Decision Date 01/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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