FDA 510(k)

Rotarex Atherectomy System

N.º K: K211738 · 2021-09-14

Fecha de decisión2021-09-14

Código de productoMCW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Rotarex Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K211738. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Rotarex Atherectomy System?

Rotarex Atherectomy System is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K211738.

When did Rotarex Atherectomy System receive FDA 510(k) clearance?

Rotarex Atherectomy System received FDA 510(k) clearance on 2021-09-14, under 510(k) number K211738.

Who is the listed applicant for Rotarex Atherectomy System?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rotarex Atherectomy System?

The FDA product code for Rotarex Atherectomy System is MCW.

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Fuente oficial

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