Datascope Corp.

Datascope Corp. — FDA 510(k) Submissions

Datascope Corp. has submitted 136 FDA 510(k) premarket notifications since 1976, of which 135 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Balloon, Intra-aortic And Control, Wire, Guide, Catheter, Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm), Introducer, Catheter, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) . Use the specialty filter in the sidebar to narrow results.