TightRail Guardian Motorized Dilator Sheath

TightRail Guardian Motorized Dilator Sheath is an FDA 510(k)-cleared medical device (K212784) manufactured by Spectranetics, 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 August 23, 2022. Regulation: 8.