# K954302: Vygon Premi-Cath - Long Term Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Jun 17, 1996 after 278 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042461: Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304 (2004), 1 descendant of its own
- K132567: Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen (2013), 0 descendants of its own

## Recalls of this device
- Jul 24, 2017 · Class II · Z-0680-2018: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyve

Source page: https://510kreport.com/device/K954302
Methodology: https://510kreport.com/methodology