20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)

Tubes, Vials, Systems, Serum Separators, Blood Collection

AVIA Vascular

The following data is part of a premarket notification filed by Avia Vascular with the FDA for 20g Open-system Ally Device Kit (av100000), 22g Open-system Ally Device Kit (av110000).

Pre-market Notification Details

Device IDK220258
510k NumberK220258
Device Name:20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant AVIA Vascular 6030 W Harold Gatty Dr. Salt Lake City,  UT  84116
ContactKevin Cook
CorrespondentJonathan Holmes
MedVenture Health 299 S Main Street, Suite 2300 Salt Lake City,  UT  84111
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-07-14

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