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510(k) Data Aggregation

K Number

Device Name

FlowArt® Vial Access Device Vented

Manufacturer

Date Cleared

2025-10-14

(132 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

To allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

Device Description

Not Found

AI/ML Overview

N/A

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