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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 the device name listed in this FDA 510(k) record. The listed applicant is Vycor Medical, Inc.. It received FDA 510(k) clearance on 2021-01-14 under 510(k) 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. The listed applicant is Vycor Medical, Inc.. The 510(k) number is K202694.

When did Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) receive FDA 510(k) clearance?

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 510(k) number K202694.

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

The FDA 510(k) record lists Vycor Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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