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FDA 510(k)

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe

K-Number: K160107 · 2016-07-29

ApplicantMerit Medical Systems, Inc.
Decision Date2016-07-29
Product CodeDXT
Advisory CommitteeCV
DecisionUnknown

Device Summary

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-07-29 under approval number K160107. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is a medical device that received FDA 510(k) clearance on 2016-07-29. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K160107.

When was DiamondTOUCH Inflation Device and Fluid Dispensing Syringe approved by the FDA?

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe received FDA 510(k) clearance on 2016-07-29, under approval number K160107.

What company makes DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

The FDA product code for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is DXT.

Related Clinical Trials

NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07067658 Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk RECRUITING NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT07442903 TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure RECRUITING NCT07292194 Clinical Trial Comparing Pain Perception in Children Using Two Different Local Anesthesia Tools COMPLETED

Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Merit Medical Systems, Inc.

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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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