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510(k) K231724

Flush Syringe (Prefilled 0.9% normal saline solution) by Spm Medicare Pvt. , Ltd. — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2023
Date Received
June 13, 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.

Other clearances by Spm Medicare Pvt. , Ltd.

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  • 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)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)