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FDA PMA

Catheter, Balloon, Urethral, Drug-Coated

Número do PMA: P210020 · 2025-06-23

RequerenteUrotronic, Inc.
Data da decisão2025-06-23
Número PMAP210020
Código do produtoQRH
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoGU

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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