
Avia Vascular
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20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) is an FDA 510(k)-cleared medical device (K220258) manufactured by Avia Vascular. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2022. Regulation: 8.