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FDA 510(k)

VYCOR SURGICAL ACCESS SYSTEMS

K-Number: K060973 · 2006-07-26

ApplicantVycor Medical, LLC
Decision Date2006-07-26
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VYCOR SURGICAL ACCESS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Vycor Medical, LLC. It received FDA 510(k) clearance on 2006-07-26 under 510(k) number K060973. 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 SURGICAL ACCESS SYSTEMS?

VYCOR SURGICAL ACCESS SYSTEMS is a medical device that received FDA 510(k) clearance on 2006-07-26. The listed applicant is Vycor Medical, LLC. The 510(k) number is K060973.

When did VYCOR SURGICAL ACCESS SYSTEMS receive FDA 510(k) clearance?

VYCOR SURGICAL ACCESS SYSTEMS received FDA 510(k) clearance on 2006-07-26, under 510(k) number K060973.

Who is the listed applicant for VYCOR SURGICAL ACCESS SYSTEMS?

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

What is the FDA product code for VYCOR SURGICAL ACCESS SYSTEMS?

The FDA product code for VYCOR SURGICAL ACCESS SYSTEMS is GZT.

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Related Devices (Code: GZT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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