FDA.report

510(k) K884913

Device
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
Applicant
MERIT MEDICAL SYSTEMS, INC.
510(k) number
K884913
Product code
DXT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-18
Date received
1988-11-28
Regulation
870.1650
Classification name
Injector And Syringe, Angiographic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
FRED LAMPROPOULOS
Address
79 W. 4500 S., Suite 9 Salt Lake City UT US 84107 84107

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
10884450297992IntelliSystem®Merit Medical Systems, Inc.2017-05-10
20884450298002IntelliSystem®Merit Medical Systems, Inc.2017-04-21
10884450297985IntelliSystem®Merit Medical Systems, Inc.2017-03-13
10884450028039IntelliSystem®Merit Medical Systems, Inc.2016-09-24
10884450024598IntelliSystem®Merit Medical Systems, Inc.2016-09-24
10884450021467IntelliSystem®Merit Medical Systems, Inc.2016-09-24
10884450006594IntelliSystem®Merit Medical Systems, Inc.2016-09-24

Legacy Summary

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FDA Review

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