Class Class II
Hemodialysis Catheter (K241581)
Description
Hemodialysis Catheter by Haolang Medical USA Corporation, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241581
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeMSD
Regulation Number876.5540
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241581
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. Hemodialysis Catheter (K241581) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203767 | Pristine Long-Term Hemodialysis Catheter | C B Bard, Inc. | 2021 |
| K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 |
| K130851 | CASCADE HEMODIALYSIS/APHERESIS CATHETER | Health Line International Corporation | 2014 |
Trace the full predicate network for K241581
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.