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510(k) K231754

Praxiject™ 0.9% NaCl by Medxl, Inc. — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2023
Date Received
June 15, 2023
Clearance Type
Special
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 by Medxl, Inc.

  • K233623 — Praxiject™ SP 0.9% NaCl (February 27, 2024)
  • K192414 — Praxiject 0.9% NaCl (February 13, 2020)
  • K171109 — Praxiject 0.9% NaCl (December 21, 2017)

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)
  • K223584 — Pre-Filled Normal Saline Flush Syringe (August 12, 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)
  • K214080 — Pentaflush (July 20, 2022)
  • K220060 — Pre-filled Syringe with Saline (June 10, 2022)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)