Class Class II
Ruby Intravascular Catheter (K243105)
Description
Ruby Intravascular Catheter by Venocare, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243105
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeFOZ
Regulation Number880.5200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243105
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. Ruby Intravascular Catheter (K243105) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2016 |
Trace the full predicate network for K243105
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.