# P830063: Gambro Fiber Plasmafilter

- Pathway: PMA
- Applicant: Vantive US Healthcare, LLC
- Decided: May 27, 1986 after 966 days
- Product code: MDP (Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma)
- Device class: 3
- 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.
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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 6, 2026 · Class II · Z-1231-2026: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Source page: https://510kreport.com/device/P830063
Methodology: https://510kreport.com/methodology