Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) is an FDA 510(k)-cleared medical device (K223929) manufactured by Innova Vascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2023. Regulation: 8.