FDA.reportPublic FDA data

510(k) K240880

Device
VitalFlow Set with Balance Biosurface
Applicant
Medtronic, Inc.
510(k) number
K240880
Product code
QJZ
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-12
Date received
2024-04-01
Regulation
870.4100
Classification name
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anna Wetherille
Address
7611 Northland Dr. Minneapolis MN US 55428 55428

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QJZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC2024-04-15
K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC2020-02-21