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510(k) K223584

Pre-Filled Normal Saline Flush Syringe by Anhui Tianyang Pharmaceutical Co., Ltd. — Product Code NGT

K223584 is an FDA 510(k) premarket notification submitted by Anhui Tianyang Pharmaceutical Co., Ltd. for the device "Pre-Filled Normal Saline Flush Syringe". The FDA issued a decision of Substantially Equivalent on August 12, 2023. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2023
Date Received
December 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

Other clearances for product code NGT

  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K233623 — Praxiject™ SP 0.9% NaCl (February 27, 2024)
  • K231724 — Flush Syringe (Prefilled 0.9% normal saline solution) (November 9, 2023)
  • K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, (September 27, 2023)
  • K230756 — TK Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (July 21, 2023)
  • K231754 — Praxiject™ 0.9% NaCl (July 13, 2023)
  • K214080 — Pentaflush (July 20, 2022)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)
  • K201286 — 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0 (August 11, 2020)

FDA data resources