FDA.report

510(k) K160107

Device
DiamondTOUCH Inflation Device And Fluid Dispensing Syringe
Applicant
Merit Medical Systems, Inc.
510(k) number
K160107
Product code
DXT  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
2016-07-29
Date received
2016-01-19
Regulation
870.1650
Classification name
Injector And Syringe, Angiographic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Dan W Lindsay
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
10884450409654DiamondTOUCH™Merit Medical Systems, Inc.2020-05-13
20884450324800DiamondTOUCH™Merit Medical Systems, Inc.2018-11-08
20884450264908DiamondTOUCH™Merit Medical Systems, Inc.2018-09-26
10884450324810DiamondTOUCH™Merit Medical Systems, Inc.2018-03-29
10884450324780DiamondTOUCH™Merit Medical Systems, Inc.2018-02-14

Legacy Summary

summary

FDA Review

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