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FDA 510(k)

PreludeSYNC DISTAL Radial Compression System

K-Number: K180723 · 2018-04-17

ApplicantMerit Medical Systems, Inc.
Decision Date2018-04-17
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PreludeSYNC DISTAL Radial Compression System is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-04-17 under approval number K180723. 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 DISTAL Radial Compression System?

PreludeSYNC DISTAL Radial Compression System is a medical device that received FDA 510(k) clearance on 2018-04-17. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K180723.

When was PreludeSYNC DISTAL Radial Compression System approved by the FDA?

PreludeSYNC DISTAL Radial Compression System received FDA 510(k) clearance on 2018-04-17, under approval number K180723.

What company makes PreludeSYNC DISTAL Radial Compression System?

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

What is the FDA product code for PreludeSYNC DISTAL Radial Compression System?

The FDA product code for PreludeSYNC DISTAL Radial Compression System is DXC.

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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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