# K200426: Acute Dual Lumen Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: Dec 24, 2020 after 307 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: 10 generations back to K001901 (2000). 27 ancestors in all.
No later device cites it as a predicate yet.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120674: Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter, Covidien (2012) Summary page 4.

## Indications for use
The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.

Source page: https://510kreport.com/device/K200426
Methodology: https://510kreport.com/methodology