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510(k) K213522

AMSafe Pre-Filled Normal Saline Flush Syringe by Amsino International, Inc. — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2022
Date Received
November 3, 2021
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 Amsino International, Inc.

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  • K220267 — AMSafe NeuFlo Needleless Connector (October 7, 2022)
  • K200051 — PUGGLE Enteral Feeding Pump and Feeding Set (September 25, 2020)
  • K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe (July 12, 2019)
  • K181445 — AMSure Hydrophilic Intermittent Catheter (October 1, 2018)
  • K181423 — AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (September 7, 2018)
  • K173665 — AMSafe Sure-Lok Needle-Free Connector (September 5, 2018)
  • K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (September 4, 2018)
  • K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip (March 30, 2018)
  • K101958 — AMSINO I.V. ADMINISTRATION AND EXTENSION SETS (September 29, 2010)

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  • K231754 — Praxiject™ 0.9% NaCl (July 13, 2023)
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