SafeSept Transseptal Guidewire

SafeSept Transseptal Guidewire is an FDA 510(k)-cleared medical device (K170671) 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 October 19, 2017. Regulation: 8.