# P990065: Sir-Spheres

- Pathway: PMA
- Applicant: Sirtex Medical, Inc.
- Decided: Mar 5, 2002 after 862 days
- Product code: NAW (Microspheres Radionuclide)
- 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 27, 2013 · Class III · Z-1162-2013: Incorrect expiration date

Source page: https://510kreport.com/device/P990065
Methodology: https://510kreport.com/methodology