FDA.report

510(k) K162988

Device
PreludeSYNC Radial Compression Device
Applicant
Merit Medical Systems, Inc.
510(k) number
K162988
Product code
DXC  
Decision
Substantially Equivalent (SESE)
Decision date
2017-01-25
Date received
2016-10-27
Regulation
870.4450
Classification name
Clamp, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ileana Davis
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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