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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 the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) 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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K160107.

When did DiamondTOUCH Inflation Device and Fluid Dispensing Syringe receive FDA 510(k) clearance?

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

Who is the listed applicant for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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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