# K113622: Orion II CT CVC

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation (Hlic)
- Decided: May 18, 2012 after 162 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: 11 generations back to K001901 (2000). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101329: Synergy CT Picc, Health Line International Corporation (2010) Summary page 3.

## Most influential descendants
- K192533: Health Line CT CVC (2019), 0 descendants of its own

## Indications for use
The ORION II 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 ORION II CT CVC.

Source page: https://510kreport.com/device/K113622
Methodology: https://510kreport.com/methodology