# K993052: Vygon 2 FR Epicutaneo Pur-Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Aug 3, 2000 after 325 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K061986: 1.9F X 20 CM Vascu-Picc, Models VP1.9S20 and VP1.9S50 (2006), 5 descendants of its own
- K091466: 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20, Vpi.9S50 (2009), 4 descendants of its own
- K102966: 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-Picc (2010), 3 descendants of its own
- K130034: Uni-Picc (2013), 2 descendants of its own
- K140270: Nexus Midline CT Catheter (2014), 1 descendant of its own

## Indications for use
The Vygon 2 FR Epicutaheo PUR Catheter is intended for use in neonates who require long term L.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids.

Source page: https://510kreport.com/device/K993052
Methodology: https://510kreport.com/methodology
