TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath

TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath is an FDA 510(k)-cleared medical device (K150360) 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 March 3, 2015. Regulation: 8.