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FDA 510(k)

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator

N.º K: K192283 · 2020-05-06

SolicitanteMedron, LLC
Fecha de decisión2020-05-06
Código de productoDRE
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Medron, LLC. It received FDA 510(k) clearance on 2020-05-06 under 510(k) number K192283. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is a medical device that received FDA 510(k) clearance on 2020-05-06. The listed applicant is Medron, LLC. The 510(k) number is K192283.

When did MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator receive FDA 510(k) clearance?

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator received FDA 510(k) clearance on 2020-05-06, under 510(k) number K192283.

Who is the listed applicant for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

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

What is the FDA product code for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

The FDA product code for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is DRE.

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Dispositivos relacionados (Código: DRE)

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.

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Fuente oficial

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

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