FDA 510(k)

PIVO(TM)

N.º K: K193569 · 2020-01-21

Fecha de decisión2020-01-21

Código de productoJKA

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Otros registros que enlistan a Velano Vascular como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.