FDA 510(k)

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

Número K: K252355 · 2025-11-26

RequerenteSb-Kawasumi Laboratories, Inc.

Data da decisão2025-11-26

Código do produtoPTI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K252355. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K252355.

When did K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing receive FDA 510(k) clearance?

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing received FDA 510(k) clearance on 2025-11-26, under 510(k) number K252355.

Who is the listed applicant for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

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

What is the FDA product code for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

The FDA product code for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is PTI.

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Outros registros que listam Sb-Kawasumi Laboratories, Inc. como candidato(a)

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Fonte oficial

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