SC HONKYTONK PTCA Balloon Dilatation Catheter (K223022)
Description
SC HONKYTONK PTCA Balloon Dilatation Catheter by Sino Medical Sciences Technology, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223022
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. SC HONKYTONK PTCA Balloon Dilatation Catheter (K223022) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K163174 | Emerge PTCA Dilatation Catheter | Boston Scientific Corporation | 2016 |
Trace the full predicate network for K223022
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.