Protaryx Transseptal Puncture Device (PTX2-001)

Protaryx Transseptal Puncture Device (PTX2-001) is an FDA 510(k)-cleared medical device (K260839) manufactured by Protaryx 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 April 9, 2026. Regulation: 8.