# K050176: Vortex EZ Vascular Access Port

- Pathway: 510(k) (Special)
- Applicant: Rita Medical Systems, Inc.
- Decided: Feb 25, 2005 after 30 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905852 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010767: Lifeport VTX Access System,Model VTX 7000 Series, Horizon Medical Products, Inc. (2001)
- K905852: Strato Plast Port Intro KT (10 FR)LPS 7013/Modified, Strato Medical Corp. (1991) Summary page 1.

## Indications for use
The Vortex EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

Source page: https://510kreport.com/device/K050176
Methodology: https://510kreport.com/methodology