FDA 510(k)

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

N.º K: K181979 · 2019-05-24

Fecha de decisión2019-05-24

Código de productoKOD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K181979. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K181979.

When did Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter receive FDA 510(k) clearance?

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter received FDA 510(k) clearance on 2019-05-24, under 510(k) number K181979.

Who is the listed applicant for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

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

What is the FDA product code for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

The FDA product code for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is KOD.

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Fuente oficial

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