PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS

Dilator, Vessel, For Percutaneous Catheterization

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude And Prelude Pro Sheath Introducers.

Pre-market Notification Details

Device IDK073035
510k NumberK073035
Device Name:PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactShirley Hyink
CorrespondentShirley Hyink
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-29
Decision Date2007-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884450054342 K073035 000
10884450015299 K073035 000
20884450331112 K073035 000

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