Bd Phaseal Closed System Transfer Device - Injector

• • Ongoing Z-2453-2025 FDA Class II ·initiated 16 Jun 2025

  Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

510(k) Number

K140591 ↗

FDA Product Code

ONB

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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