Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)— 510(k) K202694

Name: FDA 510(k) clearance K202694
Creator: U.S. Food and Drug Administration
Published: 2021-01-14

Substantially Equivalent

Vycor Medical, Inc.

FDA 510(k) clearance K202694 for Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family), Substantially Equivalent on 2021-01-14. Applicant: Vycor Medical, Inc.. Device class: 2.

Clearance details

Applicant: Vycor Medical, Inc.
Product code: Code GZT
Device class: Class 2
Regulation: 21 CFR 882.4800
Advisory panel: Neurology
Date received: 2020-09-16
Decision date: 2021-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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