FDA 510(k)

NuCath Wedge Pressure Catheter

N.º K: K213666 · 2022-10-06

Fecha de decisión2022-10-06

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

NuCath Wedge Pressure Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K213666. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NuCath Wedge Pressure Catheter?

NuCath Wedge Pressure Catheter is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K213666.

When did NuCath Wedge Pressure Catheter receive FDA 510(k) clearance?

NuCath Wedge Pressure Catheter received FDA 510(k) clearance on 2022-10-06, under 510(k) number K213666.

Who is the listed applicant for NuCath Wedge Pressure Catheter?

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

What is the FDA product code for NuCath Wedge Pressure Catheter?

The FDA product code for NuCath Wedge Pressure Catheter is DQO.

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Fuente oficial

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