Class Class II
VitalFlow Set with Balance Biosurface (K240880)
Description
VitalFlow Set with Balance Biosurface by Medtronic, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240880
Clearance Date2024-09-12
Clearance TypeTraditional
Product CodeQJZ
Regulation Number870.4100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240880
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. VitalFlow Set with Balance Biosurface (K240880) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232767 | Nautilus VF ECMO Oxygenator | Mc3, Inc. | 2023 |
| K223898 | VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants,... | 2023 |
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxy... | Medtronic, Inc. | 2023 |
| K191407 | Novalung System | Fresenius Medical Care Renal Therap... | 2020 |
Trace the full predicate network for K240880
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.