# K192533: Health Line CT CVC

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: Dec 10, 2019 after 85 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001901 (2000). 34 ancestors in all.
No later device cites it as a predicate yet.
2 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113622: Orion II CT CVC, Health Line International Corporation (Hlic) (2012) Summary page 4.

## Indications for use
The HEALTH LINE CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the HEALTH LINE CT CVC.

Source page: https://510kreport.com/device/K192533
Methodology: https://510kreport.com/methodology