K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing— 510(k) K252355

Name: FDA 510(k) clearance K252355
Creator: U.S. Food and Drug Administration
Published: 2025-11-26

Substantially Equivalent

Sb-Kawasumi Laboratories, Inc.

FDA 510(k) clearance K252355 for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing, Substantially Equivalent on 2025-11-26. Applicant: Sb-Kawasumi Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Sb-Kawasumi Laboratories, Inc.
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2025-07-29
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanagawa, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.