Pn 62290 0.22 Micron Micro Infus I.V. Exten Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914792 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET in intravenous therapy setups?

  The PN 62290 is designed specifically for microinfusion applications in intravenous therapy. Its key function is to act as an extension set while incorporating a 0.22-micron filter, which helps remove particulate matter from infused fluids, ensuring cleaner administration during precise, low-flow infusions.

• Is this device intended for reuse, or is it meant to be used only once?

  The PN 62290 is explicitly labeled as a single-use, sterile product, meaning it should only be used once per patient and then discarded. Reuse is not recommended or supported by the manufacturer.

• What types of clinical settings is this intravenous extension set approved for?

  This device is classified under product code FPA and received FDA clearance as substantially equivalent to a predicate device. It is intended for use in general hospital settings, as indicated by its advisory committee designation (HO).

• How should the PN 62290 be stored before use?

  Since the device is sterile and single-use, it should be stored in its original packaging until ready for use. Proper storage conditions (e.g., clean, dry, and protected from contamination) are critical to maintaining sterility and integrity before administration.