Shiley, Inc.

Shiley, Inc. — FDA 510(k) Submissions

Shiley, Inc. has submitted 174 FDA 510(k) premarket notifications since 1976, of which 174 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, Reservoir, Blood, Cardiopulmonary Bypass, Tube, Tracheostomy (w/wo Connector), Apparatus, Autotransfusion, Heat-exchanger, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.