NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (K250592)
Description
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) by Northeast Scientific, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250592
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. NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (K250592) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150442 | Volcano Visions PV .018 Digital IVUS Catheter | Volcano Corporation | 2015 |
Trace the full predicate network for K250592
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.