Pounce(TM) Sheath

Pounce(TM) Sheath is an FDA 510(k)-cleared medical device (K252227) manufactured by Surmodics,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 September 23, 2025. Regulation: 8.