MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)

Injector And Syringe, Angiographic

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Intelliflator(tm) & Merit Monitor(tm).

Pre-market Notification Details

Device IDK884913
510k NumberK884913
Device Name:MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
ClassificationInjector And Syringe, Angiographic
Applicant MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City,  UT  84107
ContactFred Lampropoulos
CorrespondentFred Lampropoulos
MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City,  UT  84107
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-28
Decision Date1989-04-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450298002 K884913 000
10884450297992 K884913 000
10884450297985 K884913 000
10884450028039 K884913 000
10884450024598 K884913 000
10884450021467 K884913 000
10884450006594 K884913 000

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