# K022905: Lifejet F16 Hemodialysis/Apheresis Chronic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Horizon Medical Products, Inc.
- Decided: Dec 13, 2002 after 101 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: 2 generations back to K925819 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011916: Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45 Series, Horizon Medical Products, Inc. (2001)

## Indications for use
The LifeJetTMF16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The CatheteF is intended for implantation dwell time of greater than 30 days.

Source page: https://510kreport.com/device/K022905
Methodology: https://510kreport.com/methodology