SafeSept® Transseptal Guidewire (SS-140)

SafeSept® Transseptal Guidewire (SS-140) is an FDA 510(k)-cleared medical device (K221707) 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 September 13, 2022. Regulation: 8.