FDA 510(k)

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

N.º K: K161504 · 2017-01-06

Fecha de decisión2017-01-06

Código de productoMPB

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K161504. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Cook Incorporated. The 510(k) number is K161504.

When did Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray receive FDA 510(k) clearance?

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray received FDA 510(k) clearance on 2017-01-06, under 510(k) number K161504.

Who is the listed applicant for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

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 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

The FDA product code for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is MPB.

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Fuente oficial

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