Class Class II
Tigereye ST CTO-Crossing Catheter (K230594)
Description
Tigereye ST CTO-Crossing Catheter by Avinger, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230594
Clearance Date2023-04-25
Clearance TypeTraditional
Product CodePDU
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230594
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. Tigereye ST CTO-Crossing Catheter (K230594) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2020 |
Trace the full predicate network for K230594
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.