SafeCross Transseptal Puncture and Introducer (TSP/I) System

SafeCross Transseptal Puncture and Introducer (TSP/I) System is an FDA 510(k)-cleared medical device (K203459) manufactured by East End Medical I, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 5, 2021. Regulation: 8.