# K983544: Vygon Double Lumen Picc-Catheters (4FR. and 5FR.)

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Jan 13, 1999 after 96 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062425: Lifecath S Picc and Midline Catheter (2006), 0 descendants of its own

## Indications for use
The Vygon LIFEVAC Dual Lumen PICC Catheters (4.0 Fr. and 5.0 Fr.) are intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids.

Source page: https://510kreport.com/device/K983544
Methodology: https://510kreport.com/methodology