# P910018: Liposorber (R) LA-15 System Adsorption Column, Sulfux (R) FS-05 Plasma Separator, and Tub. Syst. for Plasmapher. (LT-MA2).

- Pathway: PMA
- Applicant: Kaneka Pharma America Corp.
- Decided: Feb 21, 1996 after 1,793 days
- Product code: MMY (Lipoprotein, Low Density, Removal)
- 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
- Feb 17, 2022 · Class II · Z-0900-2022: Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication trea

Source page: https://510kreport.com/device/P910018
Methodology: https://510kreport.com/methodology