
Kalera Medical, Inc.
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Kalera Vacuum Aspiration Catheter (K-VAC) is an FDA 510(k)-cleared medical device (K200419) manufactured by Kalera Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2020. Regulation: 8.