FDA 510(k)

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

Número K: K212165 · 2022-03-10

Data da decisão2022-03-10

Código do produtoPNE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Innovative Health, LLC como candidato(a)

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Dispositivos Relacionados (Código: PNE)

K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K152090Reprocessed Steerable IntroducerSterilmed, Inc.

Fonte oficial

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