Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (K230584)
Description
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter by Vein 360, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230584
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. Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (K230584) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation | 2015 |
Trace the full predicate network for K230584
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.