Class Class II
GORE® Tri-Lobe Balloon Catheter (K250410)
Description
GORE® Tri-Lobe Balloon Catheter by W.L. Gore & Associates, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250410
Clearance Date2025-06-02
Clearance TypeTraditional
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250410
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. GORE® Tri-Lobe Balloon Catheter (K250410) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K081799 | GORE TRI-LOBE BALLOON CATHETER | W. L. Gore & Associates, Inc. | 2008 |
Trace the full predicate network for K250410
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.