K-number	K251715
Device name	FlowArt® Vial Access Device Vented
Applicant	Asset Medikal
Product code	LHI
Device class	Class II
Decision date	Oct 14, 2025
Decision	Substantially Equivalent
Regulation	880.5440

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The FlowArt® Vial Access Device Vented is an intravascular administration set that allows multiple needleless accesses to an injection medication vial. It facilitates the withdrawal or addition of drugs/solutions from or to the vial without repeated needle punctures.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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FlowArt® Vial Access Device Vented

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