DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets (K221919)
Description
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets by Hemodia Sas, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221919
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. DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets (K221919) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203480 | DOUBLEFLO system | Hemodia Sas | 2021 |
| K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | 2020 |
Trace the full predicate network for K221919
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.