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PMA de la FDA

Catheter, Balloon, Urethral, Drug-Coated

Número de PMA: P210020 · 2025-06-23

SolicitanteUrotronic, Inc.
Fecha de decisión2025-06-23
Número PMAP210020
Código de productoQRH
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorGU

Resumen del dispositivo

Catheter, Balloon, Urethral, Drug-Coated is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2025-06-23. The device is classified under product code QRH. It was reviewed by the GU advisory panel.

Preguntas frecuentes

What is the Catheter, Balloon, Urethral, Drug-Coated?

Catheter, Balloon, Urethral, Drug-Coated is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Urotronic, Inc..

When did Catheter, Balloon, Urethral, Drug-Coated receive FDA 510(k) clearance?

The clearance date for Catheter, Balloon, Urethral, Drug-Coated can be found in the official FDA records.

Who is the listed applicant for Catheter, Balloon, Urethral, Drug-Coated?

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

What is the FDA product code for Catheter, Balloon, Urethral, Drug-Coated?

The FDA product code for Catheter, Balloon, Urethral, Drug-Coated is QRH.

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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.

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