Prelude IDeal 9F Hydrophilic Sheath Introducer

Introducer, Catheter

Merit Medical Systems

The following data is part of a premarket notification filed by Merit Medical Systems with the FDA for Prelude Ideal 9f Hydrophilic Sheath Introducer.

Pre-market Notification Details

Device IDK212152
510k NumberK212152
Device Name:Prelude IDeal 9F Hydrophilic Sheath Introducer
ClassificationIntroducer, Catheter
Applicant Merit Medical Systems 1600 West Merit Parkway South Jordan,  UT  84095
ContactDavid Thomas
CorrespondentDavid Thomas
Merit Medical Systems 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-09
Decision Date2022-01-07

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