FDA 510(k)

Extra Large Check-Flo Introducer

N.º K: K203670 · 2021-02-16

Fecha de decisión2021-02-16

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Extra Large Check-Flo Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K203670. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Extra Large Check-Flo Introducer?

Extra Large Check-Flo Introducer is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Cook Incorporated. The 510(k) number is K203670.

When did Extra Large Check-Flo Introducer receive FDA 510(k) clearance?

Extra Large Check-Flo Introducer received FDA 510(k) clearance on 2021-02-16, under 510(k) number K203670.

Who is the listed applicant for Extra Large Check-Flo Introducer?

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

What is the FDA product code for Extra Large Check-Flo Introducer?

The FDA product code for Extra Large Check-Flo Introducer is DYB.

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Fuente oficial

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