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FDA 510(k)

PreludeSYNC Radial Compression Device

K-Number: K162988 · 2017-01-25

ApplicantMerit Medical Systems, Inc.
Decision Date2017-01-25
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PreludeSYNC Radial Compression Device is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-01-25 under approval number K162988. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PreludeSYNC Radial Compression Device?

PreludeSYNC Radial Compression Device is a medical device that received FDA 510(k) clearance on 2017-01-25. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K162988.

When was PreludeSYNC Radial Compression Device approved by the FDA?

PreludeSYNC Radial Compression Device received FDA 510(k) clearance on 2017-01-25, under approval number K162988.

What company makes PreludeSYNC Radial Compression Device?

PreludeSYNC Radial Compression Device is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for PreludeSYNC Radial Compression Device?

The FDA product code for PreludeSYNC Radial Compression Device is DXC.

Related Clinical Trials

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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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