Talon Transseptal Sheath

Talon Transseptal Sheath is an FDA 510(k)-cleared medical device (K231108) manufactured by Inari Medical, 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 26, 2023. Regulation: 8.