# K161504: Cook Turbo-Flo HD Acute Hemodialysis  Catheter Set/Tray

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jan 6, 2017 after 219 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 K895417 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122091: Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray, Cook, Inc. (2013) Summary page 5.

## Indications for use
The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is intended for acute hemodialysis, apheresis and hemofiltration via percutaneous insertion into the subclavian, jugular, or femoral veins. The device is a short-term use catheter (less than 30 days).

Source page: https://510kreport.com/device/K161504
Methodology: https://510kreport.com/methodology