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FDA 510(k)

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

K-Number: K212165 · 2022-03-10

ApplicantInnovative Health, LLC
Decision Date2022-03-10
Product CodePNE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2022-03-10 under approval number K212165. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath?

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Innovative Health, LLC. The 510(k) number is K212165.

When was Reprocessed Carto Vizigo Bi-Directional Guiding Sheath approved by the FDA?

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath received FDA 510(k) clearance on 2022-03-10, under approval number K212165.

What company makes Reprocessed Carto Vizigo Bi-Directional Guiding Sheath?

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Carto Vizigo Bi-Directional Guiding Sheath?

The FDA product code for Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is PNE.

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Official Source

View on FDA Database →

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

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