Class Class II
MultiStage Balloon Dilatation Catheter (K222663)
Description
MultiStage Balloon Dilatation Catheter by Dongguan TT Medical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222663
Clearance Date2023-03-09
Clearance TypeTraditional
Product CodeFGE
Regulation Number876.5010
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222663
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. MultiStage Balloon Dilatation Catheter (K222663) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K112994 | CRE DITATATION BALLON | Boston Scientific Corporation | 2012 |
Trace the full predicate network for K222663
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.