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510(k) K180151

Device
MC3 Jugular Dual Lumen Catheter
Applicant
MC3 Incorporated
510(k) number
K180151
Product code
PZS  
Decision
Substantially Equivalent (SESE)
Decision date
2018-07-16
Date received
2018-01-19
Regulation
870.4100
Classification name
Dual Lumen Ecmo Cannula
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Adam Viitala
Address
2555 Bishop Cir. W Dexter MI US 48130 48130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc.2023-10-06
K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc.2021-05-03
K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated2017-11-16

Legacy Summary#

summary

FDA Review#

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