Class Class II
Aperta NSE PTA Balloon Dilatation Catheter (K243944)
Description
Aperta NSE PTA Balloon Dilatation Catheter by Goodman Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243944
Clearance Date2025-04-22
Clearance TypeTraditional
Product CodePNO
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243944
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. Aperta NSE PTA Balloon Dilatation Catheter (K243944) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/A... | Goodman Co., Ltd. | 2024 |
Trace the full predicate network for K243944
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.