# K102833: Disposable Hemodialysis Access Catheter Sets

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Nanhai Bai HE Medical Technology Co., Ltd.
- Decided: Nov 18, 2011 after 415 days
- Product code: MPB (Catheter, Hemodialysis, Non-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: 3 generations back to K941851 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090102: Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis Catheters, C.R. Bard, Inc. (2009) Summary page 2.
- K063355: D-Line Catheter ST, Double Lumen ST; Extra Flow, Novosci Corp. (2007) Summary page 2.

## Indications for use
Disposable H-emodialysis Access Catheter Sets, including single lumen and dual lumen, are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis via the internal jugular, stzbclavian or femoral vein.

Source page: https://510kreport.com/device/K102833
Methodology: https://510kreport.com/methodology