Class Class II
Highlander™ 014 PTA Balloon Dilatation Catheter (K223177)
Description
Highlander™ 014 PTA Balloon Dilatation Catheter by C.R. Bard, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223177
Clearance Date2023-01-20
Clearance TypeTraditional
Product CodeLIT
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223177
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. Highlander™ 014 PTA Balloon Dilatation Catheter (K223177) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | Bard Peripheral Vascular, Inc. | 2019 |
Trace the full predicate network for K223177
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.