# P110003: LEGOO

- Pathway: PMA
- Applicant: Genzyme Corp.
- Decided: Sep 28, 2011 after 240 days
- Product code: OBC (Occluder, Internal Vessel, Temporary)
- Device class: 3
- Recalls of this device: 18 (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
- Jun 21, 2013 · Class II · Z-2145-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2141-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2139-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2152-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2146-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2153-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2143-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2144-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2140-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2142-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2155-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2147-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2148-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2149-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2154-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2151-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2156-2013: Product contains particulates (fibers)
- Jun 21, 2013 · Class II · Z-2150-2013: Product contains particulates (fibers)

Source page: https://510kreport.com/device/P110003
Methodology: https://510kreport.com/methodology