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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2022-03-10 under 510(k) 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. The listed applicant is Innovative Health, LLC. The 510(k) number is K212165.

When did Reprocessed Carto Vizigo Bi-Directional Guiding Sheath receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprocessed Carto Vizigo Bi-Directional Guiding Sheath?

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

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.

Other records listing Innovative Health, LLC as applicant

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Related Devices (Code: PNE)

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.

K250305Reprocessed Agilis NxT Steerable IntroducerInnovative HealthK250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLCK230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLCK170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLCK152090Reprocessed Steerable IntroducerSterilmed, Inc.

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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