PROGUIDE CHRONIC DIALYSIS 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 Proguide Chronic Dialysis Catheter.

Pre-market Notification Details

Device IDK090148
510k NumberK090148
Device Name:PROGUIDE CHRONIC DIALYSIS CATHETER
ClassificationCatheter, Hemodialysis, Implanted
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactSusan Christensen
CorrespondentSusan Christensen
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-21
Decision Date2009-04-13
Summary:summary

NIH GUDID Devices

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