PRELUDEEASE HYDROPHILIC 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 Preludeease Hydrophilic Sheath Introducer.

Pre-market Notification Details

Device IDK140543
510k NumberK140543
Device Name:PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
ClassificationIntroducer, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactMichaela Rivkowich
CorrespondentMichaela Rivkowich
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-04
Decision Date2014-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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20884450526334 K140543 000

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