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FDA 510(k)

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

K-Number: K202694 · 2021-01-14

ApplicantVycor Medical, Inc.
Decision Date2021-01-14
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is a medical device manufactured by Vycor Medical, Inc.. It received FDA 510(k) clearance on 2021-01-14 under approval number K202694. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is a medical device that received FDA 510(k) clearance on 2021-01-14. It is manufactured by Vycor Medical, Inc.. The 510(k) number is K202694.

When was Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) approved by the FDA?

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) received FDA 510(k) clearance on 2021-01-14, under approval number K202694.

What company makes Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is manufactured by Vycor Medical, Inc..

What is the FDA product code for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

The FDA product code for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is GZT.

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Official Source

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