S-MAK XL

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 S-mak Xl.

Pre-market Notification Details

Device IDK190175
510k NumberK190175
Device Name:S-MAK XL
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant Merit Medical Systems Inc. 1600 West Merit Parkway South Jordan,  UT  84095
ContactDavid Thomas
CorrespondentDavid Thomas
Merit Medical Systems Inc. 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-01
Decision Date2019-04-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884450410438 K190175 000

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