PRELUDE 7F SHORT SHEATH INTRODUCER

Introducer, Catheter

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude 7f Short Sheath Introducer.

Pre-market Notification Details

Device IDK122190
510k NumberK122190
Device Name:PRELUDE 7F SHORT SHEATH INTRODUCER
ClassificationIntroducer, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton,  TX  77515
ContactDan Clark
CorrespondentDan Clark
MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton,  TX  77515
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-24
Decision Date2012-08-17
Summary:summary

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