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PMA de la FDA

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

Número de PMA: P200041 · 2026-07-31

SolicitanteOrbusNeich Medical (Shenzhen) Co., Ltd.
Fecha de decisión2026-07-31
Número PMAP200041
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 OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2026-07-31. 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 2026-07-31. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd..

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 OrbusNeich Medical (Shenzhen) Co., Ltd. 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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