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PMA de la FDA

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Número de PMA: P190019 · 2026-08-04

SolicitanteBoston Scientific Corporation
Fecha de decisión2026-08-04
Número PMAP190019
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 Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-04. 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 2026-08-04. The listed applicant is Boston Scientific Corporation.

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 Boston Scientific Corporation 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 →

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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