# P040014: Ibi Therapy Cardiac Ablation System                    Ers/ 1500T RF Generator

- Pathway: PMA
- Applicant: Irvine Biomedical, Inc.
- Decided: Jan 14, 2005 after 305 days
- Product code: LPB (Cardiac Ablation Percutaneous Catheter)
- Device class: 3
- Recalls of this device: 3 (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 10, 2011 · Not classified · Z-3256-2011: The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ens
- Feb 10, 2011 · Not classified · Z-3257-2011: The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ens
- Feb 10, 2011 · Not classified · Z-3255-2011: The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ens

Source page: https://510kreport.com/device/P040014
Methodology: https://510kreport.com/methodology