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FDA 510(k)

Vivio System

K-Number: K183710 · 2019-10-04

ApplicantAvicena, LLC
Decision Date2019-10-04
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vivio System is the device name listed in this FDA 510(k) record. The listed applicant is Avicena, LLC. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K183710. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vivio System?

Vivio System is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Avicena, LLC. The 510(k) number is K183710.

When did Vivio System receive FDA 510(k) clearance?

Vivio System received FDA 510(k) clearance on 2019-10-04, under 510(k) number K183710.

Who is the listed applicant for Vivio System?

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

What is the FDA product code for Vivio System?

The FDA product code for Vivio System is DQD.

Other records listing Avicena, LLC as applicant

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.

K223905Vivio® LVEDP System

Related Devices (Code: DQD)

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

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