FDA.reportPublic FDA data

510(k) K232480

Device
ProtekDuo Veno-Venous Cannula Sets
Applicant
Cardiacassist, Inc.
510(k) number
K232480
Product code
PZS
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-06
Date received
2023-08-16
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
Mariah McMinn
Address
620 Alpha Dr. Suite 2 Pittsburg PA US 15238 15238

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
K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc.2021-05-03
K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated2018-07-16
K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated2017-11-16