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PMA de la FDA

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Número de PMA: P210025 · 2025-06-06

SolicitanteSurmodics,Inc.
Fecha de decisión2025-06-06
Número PMAP210025
Código de productoONU
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Drug-Eluting Peripheral Transluminal Angioplasty Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2025-06-06. The device is classified under product code ONU. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Drug-Eluting Peripheral Transluminal Angioplasty Catheter?

Drug-Eluting Peripheral Transluminal Angioplasty Catheter is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Surmodics,Inc..

When did Drug-Eluting Peripheral Transluminal Angioplasty Catheter receive FDA 510(k) clearance?

The clearance date for Drug-Eluting Peripheral Transluminal Angioplasty Catheter can be found in the official FDA records.

Who is the listed applicant for Drug-Eluting Peripheral Transluminal Angioplasty Catheter?

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

What is the FDA product code for Drug-Eluting Peripheral Transluminal Angioplasty Catheter?

The FDA product code for Drug-Eluting Peripheral Transluminal Angioplasty Catheter is ONU.

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Fuente oficial

Ver en la base de datos de la FDA →

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