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PMA de la FDA

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Número de PMA: P050018 · 2025-04-04

SolicitanteSpectranetics Corp.
Fecha de decisión2025-04-04
Número PMAP050018
Código de productoNWX
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2025-04-04. The device is classified under product code NWX. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring?

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Spectranetics Corp..

When did Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring receive FDA 510(k) clearance?

The clearance date for Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring can be found in the official FDA records.

Who is the listed applicant for Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring?

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

What is the FDA product code for Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring?

The FDA product code for Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring is NWX.

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Fuente oficial

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