FDA 510(k)

Occlusion Perfusion Catheter

N.º K: K153488 · 2016-02-25

SolicitanteAdvanced Catheter Therapies, Inc.

Fecha de decisión2016-02-25

Código de productoQEY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Occlusion Perfusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Catheter Therapies, Inc.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K153488. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Occlusion Perfusion Catheter?

Occlusion Perfusion Catheter is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Advanced Catheter Therapies, Inc.. The 510(k) number is K153488.

When did Occlusion Perfusion Catheter receive FDA 510(k) clearance?

Occlusion Perfusion Catheter received FDA 510(k) clearance on 2016-02-25, under 510(k) number K153488.

Who is the listed applicant for Occlusion Perfusion Catheter?

The FDA 510(k) record lists Advanced Catheter Therapies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Occlusion Perfusion Catheter?

The FDA product code for Occlusion Perfusion Catheter is QEY.

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Fuente oficial

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