CONCIERGE GUIDING CATHETER

Catheter, Percutaneous

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Concierge Guiding Catheter.

Pre-market Notification Details

Device IDK121051
510k NumberK121051
Device Name:CONCIERGE GUIDING CATHETER
ClassificationCatheter, Percutaneous
Applicant MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton,  TX  77515
ContactMichaela Rivkowich
CorrespondentMichaela Rivkowich
MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton,  TX  77515
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-06
Decision Date2012-06-13
Summary:summary

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