The following data is part of a premarket notification filed by Merit Medical Systems with the FDA for Prelude Ideal 9f Hydrophilic Sheath Introducer.
|Device Name:||Prelude IDeal 9F Hydrophilic Sheath Introducer|
|Applicant||Merit Medical Systems 1600 West Merit Parkway South Jordan, UT 84095|
Merit Medical Systems 1600 West Merit Parkway South Jordan, UT 84095
|CFR Regulation Number||870.1340 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|