# P040042: Therapy Dual 8 Cardiac Ablation System,Theram 8MM Thermister Ablation Catheter Safire TX Ablation Catheter

- Pathway: PMA
- Applicant: Irvine Biomedical,Inc.(Ibi)
- Decided: Nov 18, 2005 after 410 days
- Product code: OAD (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter)
- Device class: 3
- Recalls of this device: 4 (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
- Nov 25, 2009 · Not classified · Z-0594-2010: This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted
- Nov 25, 2009 · Not classified · Z-0593-2010: This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted
- Nov 8, 2006 · Not classified · Z-0310-2007: Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional op
- Nov 8, 2006 · Not classified · Z-0309-2007: Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional op

Source page: https://510kreport.com/device/P040042
Methodology: https://510kreport.com/methodology