FDA 510(k)

Crosser iQ CTO Recanalization System

N.º K: K203363 · 2021-08-12

Fecha de decisión2021-08-12

Código de productoPDU

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Crosser iQ CTO Recanalization 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 2021-08-12 under 510(k) number K203363. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Crosser iQ CTO Recanalization System?

Crosser iQ CTO Recanalization System is a medical device that received FDA 510(k) clearance on 2021-08-12. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K203363.

When did Crosser iQ CTO Recanalization System receive FDA 510(k) clearance?

Crosser iQ CTO Recanalization System received FDA 510(k) clearance on 2021-08-12, under 510(k) number K203363.

Who is the listed applicant for Crosser iQ CTO Recanalization 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 Crosser iQ CTO Recanalization System?

The FDA product code for Crosser iQ CTO Recanalization System is PDU.

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Fuente oficial

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