Class Class II
Tunnel Crossing Catheter (K221163)
Description
Tunnel Crossing Catheter by Tractus Vascular, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221163
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodePDU
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221163
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. Tunnel Crossing Catheter (K221163) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183305 | Crossing Support Catheter | Tractus Vascular, LLC | 2019 |
| K180889 | Tractus Crossing Support Catheter | Tractus Vascular, LLC | 2018 |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | Bridgepoint Medical | 2012 |
Trace the full predicate network for K221163
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.