FDA.report

510(k) K161921

Device
SwiftNINJA Microcatheter
Applicant
MERIT MEDICAL SYSTEMS, INC.
510(k) number
K161921
Product code
KRA  
Decision
Substantially Equivalent (SESE)
Decision date
2016-11-04
Date received
2016-07-13
Regulation
870.1210
Classification name
Catheter, Continuous Flush
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
LUKE MEIDELL
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
00884450324004Merit SwiftNINJA®Merit Medical Systems, Inc.2019-08-13
00884450323878Merit SwiftNINJA®Merit Medical Systems, Inc.2017-12-18
00884450297551Merit SwiftNINJA®Merit Medical Systems, Inc.2017-01-18
00884450278505Merit SwiftNINJA®Merit Medical Systems, Inc.2016-12-07

Legacy Summary

summary

FDA Review

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