# K954112: Vygon Lifevac Mid-Line Tray

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: May 9, 1996 after 283 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 9, 2003 · Not classified · Z-0849-03: Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
- Apr 9, 2003 · Not classified · Z-0850-03: Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.

Source page: https://510kreport.com/device/K954112
Methodology: https://510kreport.com/methodology