Needle Free Transseptal Cannula

Needle Free Transseptal Cannula is an FDA 510(k)-cleared medical device (K172934) manufactured by Pressure Products Medical Device Manufacturing, 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 February 15, 2018. Regulation: 8.