MERIT IMPRESS DIAGNOSTIC CATHETER

Catheter, Intravascular, Diagnostic

MERIT MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK053171
510k NumberK053171
Device Name:MERIT IMPRESS DIAGNOSTIC CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactStephanie Erskine
CorrespondentJ.a. Van Vugt
KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont,  PA  18914
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-11-14
Decision Date2006-01-19
Summary:summary

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