Tri-Wedge PTA Scoring Balloon Dilatation Catheter (K241478)
Description
Tri-Wedge PTA Scoring Balloon Dilatation Catheter by Brosmed Medical Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241478
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. Tri-Wedge PTA Scoring Balloon Dilatation Catheter (K241478) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017 |
| K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015 |
Trace the full predicate network for K241478
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.