Class Class II
OXY-1 System (K223161)
Description
OXY-1 System by Abiomed, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223161
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodeDTZ
Regulation Number870.4350
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223161
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. OXY-1 System (K223161) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200109 | OXY-1 System | Abiomed, Inc. | 2020 |
Trace the full predicate network for K223161
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.