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FDA 510(k)

Sublime Radial Access 018 RX Dilatation Catheter

N.º K: K211044 · 2021-06-16

SolicitanteCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,
Fecha de decisión2021-06-16
Código de productoLIT
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sublime Radial Access 018 RX Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K211044. 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 Sublime Radial Access 018 RX Dilatation Catheter?

Sublime Radial Access 018 RX Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. The 510(k) number is K211044.

When did Sublime Radial Access 018 RX Dilatation Catheter receive FDA 510(k) clearance?

Sublime Radial Access 018 RX Dilatation Catheter received FDA 510(k) clearance on 2021-06-16, under 510(k) number K211044.

Who is the listed applicant for Sublime Radial Access 018 RX Dilatation Catheter?

The FDA 510(k) record lists Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sublime Radial Access 018 RX Dilatation Catheter?

The FDA product code for Sublime Radial Access 018 RX Dilatation Catheter 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

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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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