RAIN Sheath™ Tibial Pedal Introducer

RAIN Sheath™ Tibial Pedal Introducer is an FDA 510(k)-cleared medical device (K230704) manufactured by Cordis US Corp. 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 23, 2023. Regulation: 8.