FDA 510(k)

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set

Número K: K242003 · 2024-12-16

Data da decisão2024-12-16

Código do produtoJXG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2024-12-16 under 510(k) number K242003. 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 XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set?

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is Aesculap, Inc.. The 510(k) number is K242003.

When did XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set receive FDA 510(k) clearance?

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set received FDA 510(k) clearance on 2024-12-16, under 510(k) number K242003.

Who is the listed applicant for XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set?

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

What is the FDA product code for XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set?

The FDA product code for XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set is JXG.

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Fonte oficial

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