# K222170: Power Acute Triple Lumen Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: Jan 13, 2023 after 176 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, 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: 9 generations back to K001901 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
4 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102605: Mahurkar Triple Lumen Dialysis Catheter, Covidien, LLC, Formerly Registered AS Tyco Healthca (2010) Summary page 4.

## Indications for use
The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K222170
Methodology: https://510kreport.com/methodology