FDA 510(k)

SureFlo EVD Catheter

Número K: K170599 · 2017-08-31

Data da decisão2017-08-31

Código do produtoJXG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SureFlo EVD Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arkis Biosciences, Inc.. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K170599. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SureFlo EVD Catheter?

SureFlo EVD Catheter is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Arkis Biosciences, Inc.. The 510(k) number is K170599.

When did SureFlo EVD Catheter receive FDA 510(k) clearance?

SureFlo EVD Catheter received FDA 510(k) clearance on 2017-08-31, under 510(k) number K170599.

Who is the listed applicant for SureFlo EVD Catheter?

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

What is the FDA product code for SureFlo EVD Catheter?

The FDA product code for SureFlo EVD Catheter is JXG.

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