Medical Device Manufacturer · US , Boca Raton , FL

Vycor Medical, Inc.

1 submissions · 1 cleared · Since 2021

Total

Cleared

Denied

Vycor Medical, Inc. — FDA 510(k) Submissions

Vycor Medical, Inc. has submitted 1 FDA 510(k) premarket notifications since 2021, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Retractor, Self-retaining, For Neurosurgery . Use the specialty filter in the sidebar to narrow results.

1 devices

1–1 of 1

Vycor Medical Viewsite Brain Access System (?VBAS?) and VBAS with Alignment Clip (?VBAS AC?) (together the ?VBAS Family?)

K202694 · GZT Retractor,... · Neurology

Jan 2021 120d

Vycor Medical, Inc.

Vycor Medical, Inc. — FDA 510(k) Submissions

Filters