# K241581: Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Haolang Medical USA Corporation
- Decided: May 16, 2025 after 347 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 53 ancestors in all.
No later device cites it as a predicate yet.
4 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130851: Cascade Hemodialysis/Apheresis Catheter, Health Line International Corporation (2014) Summary page 5.
- K202150: GlidePath 7.5F Long-Term Dialysis Catheter, C.R. Bard, Inc. (2020) Summary page 5.
- K203767: Pristine Long-Term Hemodialysis Catheter, C B Bard, Inc. (2021) Summary page 6.

## Indications for use
- The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis. * It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient. * Alternate insertion sites include subclavian vein as required. * Catheters greater than 40 cm are intended for femoral vein insertion. * The curved Hemodialysis Catheter is intended for internal jugular vein insertion. * 8-10Fr Hemodialysis Catheters can be used in pediatric patients.

Source page: https://510kreport.com/device/K241581
Methodology: https://510kreport.com/methodology