R2P Destination Slender Guiding Sheath

R2P Destination Slender Guiding Sheath is an FDA 510(k)-cleared medical device (K193125) manufactured by Terumo Medical Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2020. Regulation: 8.