Class Class II
Dorado™ PTA Balloon Dilatation Catheter (K250219)
Description
Dorado™ PTA Balloon Dilatation Catheter by Bard Peripheral Vascular, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250219
Clearance Date2025-06-17
Clearance TypeTraditional
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250219
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. Dorado™ PTA Balloon Dilatation Catheter (K250219) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K072283 | DORADO PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2007 |
Trace the full predicate network for K250219
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.