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FDA 510(k)

AMSafe(R) Pre-Filled Normal Saline Flush Syringe

K-Number: K183473 · 2019-07-12

ApplicantAmsino International, Inc.
Decision Date2019-07-12
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is a medical device manufactured by Amsino International, Inc.. It received FDA 510(k) clearance on 2019-07-12 under approval number K183473. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Amsino International, Inc.. The 510(k) number is K183473.

When was AMSafe(R) Pre-Filled Normal Saline Flush Syringe approved by the FDA?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2019-07-12, under approval number K183473.

What company makes AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is manufactured by Amsino International, Inc..

What is the FDA product code for AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

The FDA product code for AMSafe(R) Pre-Filled Normal Saline Flush Syringe is NGT.

Related Clinical Trials

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Other Devices by Amsino International, Inc.

K181445AMSure Hydrophilic Intermittent Catheter K181423AMSure Sterile Water, and Sterile Normal Saline for Wound Flush K173665AMSafe Sure-Lok Needle-Free Connector K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water K171857AMSure® Enteral Feeding Syringe with ENFit Tip K200051PUGGLE Enteral Feeding Pump and Feeding Set

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Related Devices (Code: NGT)

K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company K171109Praxiject 0.9% NaClMedxl, Inc. K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company K1733480.9% Sodium Chloride Injection, USPMedline Industries, Inc. K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeMedline Industries, Inc. K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouchNurse Assist, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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