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510(k) K221078

Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use by Sichuan Prius Biotechnology Co., Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2022
Date Received
April 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Sichuan Prius Biotechnology Co., Ltd.

  • K221069 — Infusion Sets for Single Use with Needles (November 21, 2022)
  • K221075 — Infusion Sets for Single Use (November 21, 2022)
  • K221068 — Sterile Hypodermic Syringes for Single Use with Needles (October 4, 2022)
  • K221066 — Sterile Hypodermic Needles for Single Use (October 4, 2022)
  • K221080 — Sterile Safety Hypodermic Needles for Single Use (October 4, 2022)
  • K221073 — Sterile Hypodermic Syringes for Single Use with Safety Needles (October 4, 2022)
  • K221079 — Sterile Hypodermic Syringes for Single Use (October 4, 2022)
  • K210908 — Surgical Mask (September 26, 2021)

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  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)