K-number	K180723
Device name	PreludeSYNC DISTAL Radial Compression System
Applicant	Merit Medical Systems, Inc.
Product code	DXC
Device class	Class II
Decision date	Apr 17, 2018
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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PreludeSYNC DISTAL Radial Compression System

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