PRELUDE 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 Short Sheath Introducer.

Pre-market Notification Details

Device IDK082063
510k NumberK082063
Device Name:PRELUDE SHORT SHEATH INTRODUCER
ClassificationIntroducer, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactJerrie Hendrickson
CorrespondentJerrie Hendrickson
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 Received2008-07-21
Decision Date2008-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450123847 K082063 000
20884450015319 K082063 000
20884450015326 K082063 000
20884450015333 K082063 000
20884450015340 K082063 000
20884450015357 K082063 000
20884450015364 K082063 000
20884450015371 K082063 000
20884450015388 K082063 000
20884450015395 K082063 000
20884450015401 K082063 000
20884450015418 K082063 000
20884450123779 K082063 000
20884450123786 K082063 000
20884450123809 K082063 000
20884450015302 K082063 000

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