TidalPort-AP Implantable Apheresis Vascular Access Port

TidalPort-AP Implantable Apheresis Vascular Access Port is an FDA 510(k)-cleared medical device (K192291) manufactured by Norfolk Medical Products, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2020. Regulation: 8.