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FDA 510(k)

PROTEUS PTA Balloon Catheter with Embolic Capture Feature

N.º K: K172494 · 2017-12-15

SolicitanteAngioslide, Ltd.
Fecha de decisión2017-12-15
Código de productoLIT
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

PROTEUS PTA Balloon Catheter with Embolic Capture Feature is the device name listed in this FDA 510(k) record. The listed applicant is Angioslide, Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172494. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PROTEUS PTA Balloon Catheter with Embolic Capture Feature?

PROTEUS PTA Balloon Catheter with Embolic Capture Feature is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Angioslide, Ltd.. The 510(k) number is K172494.

When did PROTEUS PTA Balloon Catheter with Embolic Capture Feature receive FDA 510(k) clearance?

PROTEUS PTA Balloon Catheter with Embolic Capture Feature received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172494.

Who is the listed applicant for PROTEUS PTA Balloon Catheter with Embolic Capture Feature?

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

What is the FDA product code for PROTEUS PTA Balloon Catheter with Embolic Capture Feature?

The FDA product code for PROTEUS PTA Balloon Catheter with Embolic Capture Feature is LIT.

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Dispositivos relacionados (Código: LIT)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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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