Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter is an FDA 510(k)-cleared medical device (K173686) manufactured by Cook Incorporated. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2018. Regulation: 8.