Name: Predicase
Price: 199 USD

K-number	K252355
Device name	K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
Applicant	Sb-Kawasumi Laboratories, Inc.
Product code	PTI
Device class	Class II
Decision date	Nov 26, 2025
Decision	Substantially Equivalent
Regulation	880.5570

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.