FDA 510(k)

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

N.º K: K201806 · 2021-06-23

SolicitanteSterilmed Inc. (Johnson and Johnson)

Fecha de decisión2021-06-23

Código de productoMTD

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed Inc. (Johnson and Johnson). It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K201806. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is a medical device that received FDA 510(k) clearance on 2021-06-23. The listed applicant is Sterilmed Inc. (Johnson and Johnson). The 510(k) number is K201806.

When did Reprocessed PentaRay Nav eco High-Density Mapping Catheter receive FDA 510(k) clearance?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter received FDA 510(k) clearance on 2021-06-23, under 510(k) number K201806.

Who is the listed applicant for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

The FDA 510(k) record lists Sterilmed Inc. (Johnson and Johnson) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

The FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter is MTD.

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Fuente oficial

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