Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is an FDA 510(k)-cleared medical device (K232037) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2024. Regulation: 8.