...)-clearance process includes proving the novel device is substantially equivalent to a previously cleared predicate device. For the CETCS device, we have identified the Cleveland Multiport Catheter (CMC) as our predicate device. In this work, we test infusion pump flow rate, high-pressure flow rate...

... (branch-out). We are preparing CETCS for regulatory pathway application to advance it further toward clinical and human trials. In this paper, we performed three performance tests: infusion pressure, leakage, and constant pressure flow rate tests required by the FDA to file a traditional 510(K) based upon...