FDA 510(k)

PIVO(TM)

Número K: K193569 · 2020-01-21

Data da decisão2020-01-21

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

PIVO(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Velano Vascular. It received FDA 510(k) clearance on 2020-01-21 under 510(k) number K193569. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PIVO(TM)?

PIVO(TM) is a medical device that received FDA 510(k) clearance on 2020-01-21. The listed applicant is Velano Vascular. The 510(k) number is K193569.

When did PIVO(TM) receive FDA 510(k) clearance?

PIVO(TM) received FDA 510(k) clearance on 2020-01-21, under 510(k) number K193569.

Who is the listed applicant for PIVO(TM)?

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

What is the FDA product code for PIVO(TM)?

The FDA product code for PIVO(TM) is JKA.

Outros registros que listam Velano Vascular como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K201237Velano Vascular Blood Collection Adapter K200439Velano ExT Extension Set K190604PIVO K182897Velano Vascular Q2 Extension Set K163508PIVO K152924TIVA¿

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Fonte oficial

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