# K031718: Lifevalve Central Venous Cathter

- Pathway: 510(k) (Special)
- Applicant: Horizon Medical Products, Inc.
- Decided: Jul 2, 2003 after 29 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- 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 K924851 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924851: Strato Medical Single Lumen Valved Catheter, Strato Medical Corp. (1993) Summary page 1.

## Indications for use
The Lifevalve Central Venous Catheter is indicated for patient therapy requiring acute or long-term (chronic) central venous access for the infusion of medications, parenteral solutions, parenteral nutrition solutions, or blood products, and for the withdrawal of blood samples.

Source page: https://510kreport.com/device/K031718
Methodology: https://510kreport.com/methodology