Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter

Catheter, Hemodialysis, Implanted

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Centros Long-term Hemodialysis Catheter, Centrosflo Long-term Hemodialysis Catheter.

Pre-market Notification Details

Device IDK151967
510k NumberK151967
Device Name:Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
ClassificationCatheter, Hemodialysis, Implanted
Applicant Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
ContactSusan Christensen
CorrespondentSusan Christensen
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-16
Decision Date2016-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884450295585 K151967 000
10884450276089 K151967 000
10884450276126 K151967 000
10884450276171 K151967 000
10884450276188 K151967 000
10884450276195 K151967 000
10884450276201 K151967 000
10884450276218 K151967 000
10884450276225 K151967 000
10884450276232 K151967 000
10884450276249 K151967 000
20884450276253 K151967 000
10884450276263 K151967 000
20884450276277 K151967 000
10884450276287 K151967 000
10884450295547 K151967 000
20884450276055 K151967 000

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