Home / 510(k) Clearances / K231161

510(k) K231161

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2023
Date Received
April 24, 2023
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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  • 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)
  • K223584 — Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K231754 — Praxiject™ 0.9% NaCl (July 13, 2023)
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  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)