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510(k) K250884

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe by Becton, Dickinson and Company — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2025
Date Received
March 24, 2025
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.

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Other clearances for product code NGT

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  • K230756 — TK Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K223584 — 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)
  • K220060 — Pre-filled Syringe with Saline (June 10, 2022)
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