Accusafe Transseptal Guidewire (GTR31180, GTR31230)

Accusafe Transseptal Guidewire (GTR31180, GTR31230) is an FDA 510(k)-cleared medical device (K240246) manufactured by Synaptic Medical Corporation. 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 25, 2024. Regulation: 8.