Abiomed, Inc.

Abiomed, Inc. — FDA 510(k) Submissions

Abiomed, Inc. has submitted 19 FDA 510(k) premarket notifications since 1989, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Introducer, Catheter, Pump, Blood, Cardiopulmonary Bypass, Non-roller Type, System, Balloon, Intra-aortic And Control, Oxygenator, Cardiopulmonary Bypass, Gauge, Depth, Instrument, Dental . Use the specialty filter in the sidebar to narrow results.