FX 15 The Terumo Cardiovascular Systems / Filtration Efficiency Substantial Equivalence Comp / Tcrumo Corporation / Circulating Blood Limited / M.D. / Terumo Corporation / Terumo Cardiovascular Systems Corporation / Terurno Corporation / Terumno Corporation / Terumio Cardiovascular Systems Corporation / Systems Corporation / CAPLOXO FX15 / Terurno Cardiovascular Systems Corporation / K140774 Trade / Cardiovascular Systems Corporation / Teruino Cardiovascular Systems Corporation / /
Event
FDA Phase / /
Facility
Facility Registration No. / /
IndustryTerm
subject device / gas exchange / porous fiber technology / stainless steel / announcements concerning your device / predicate devices / predicate device / technology/principles / gas flows / manufacturing practice requirements / gas-phase environment / andFlX2S devices / oxygenator/arterial filter devices / marketed predicate devices / manufacturing practice / oxygenator device / gas exchange needs / stainless steel acts / steel / Internet address http / /
Organization
Division of Postmarket Surveillance / Division of Industry and Consumer Education / FDA / Cardiovascular Devices Office / DEPARTMENT OF HEALTH / Device Evaluation Center for Devices and Radiological Health / /
Person
Silver Spring / Eileen Dorsey / / /
Position
Manager 125 Blue Ball Road Elkton / Post Operative / Regulatory Affairs Manager / General / CQE Regulatory Affairs Manager / Director Division / perfusionist / /
©TERUMO~ K140774 JUN[removed]SECTION[removed]k) Summary