PIVO(TM)

Tubes, Vials, Systems, Serum Separators, Blood Collection

Velano Vascular

The following data is part of a premarket notification filed by Velano Vascular with the FDA for Pivo(tm).

Pre-market Notification Details

Device IDK193569
510k NumberK193569
Device Name:PIVO(TM)
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Velano Vascular 221 Pine St #200 San Francisco,  CA  94104
ContactTiffini Wittwer
CorrespondentTiffini Wittwer
Velano Vascular 221 Pine St #200 San Francisco,  CA  94104
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelGeneral Hospital
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-01-21

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