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FDA 510(k)

Merit Coronary Control Syringe

K-Number: K163084 · 2017-06-15

ApplicantMerit Medical Systems, Inc.
Decision Date2017-06-15
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Merit Coronary Control Syringe is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-06-15 under approval number K163084. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merit Coronary Control Syringe?

Merit Coronary Control Syringe is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K163084.

When was Merit Coronary Control Syringe approved by the FDA?

Merit Coronary Control Syringe received FDA 510(k) clearance on 2017-06-15, under approval number K163084.

What company makes Merit Coronary Control Syringe?

Merit Coronary Control Syringe is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Merit Coronary Control Syringe?

The FDA product code for Merit Coronary Control 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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