# P060019: Ibi Therapy Cool Path Ablation Catheter & Ibi-1500T9 RF

- Pathway: PMA
- Applicant: Irvine Biomedical, Inc.
- Decided: Mar 16, 2007 after 290 days
- Product code: OAD (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter)
- 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
- Jan 5, 2012 · Not classified · Z-1032-2012: Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.

Source page: https://510kreport.com/device/P060019
Methodology: https://510kreport.com/methodology