PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is an FDA 510(k)-cleared medical device (K221029) manufactured by Synovis Life Technologies, 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 October 18, 2022. Regulation: 8.