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PMA de la FDA

Drug-coated peripheral transluminal angioplasty catheter

Número de PMA: P170003 · 2026-07-09

SolicitanteLutonix
Fecha de decisión2026-07-09
Número PMAP170003
Código de productoPRC
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Drug-coated peripheral transluminal angioplasty catheter is the device name listed in this FDA 510(k) record. The listed applicant is Lutonix. It received FDA 510(k) clearance on 2026-07-09. The device is classified under product code PRC. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Drug-coated peripheral transluminal angioplasty catheter?

Drug-coated peripheral transluminal angioplasty catheter is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Lutonix.

When did Drug-coated peripheral transluminal angioplasty catheter receive FDA 510(k) clearance?

The clearance date for Drug-coated peripheral transluminal angioplasty catheter can be found in the official FDA records.

Who is the listed applicant for Drug-coated peripheral transluminal angioplasty catheter?

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

What is the FDA product code for Drug-coated peripheral transluminal angioplasty catheter?

The FDA product code for Drug-coated peripheral transluminal angioplasty catheter is PRC.

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Fuente oficial

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