# K982232: Modification of the Ibi-1100 Steerable Electrophysiology Catheter System

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, Inc.
- Decided: Jul 25, 1998 after 30 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 6 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K171277: Reprocessed Inquiry Steerable Diagnostic EP Catheter (2017), 1 descendant of its own
- K081329: Reprocessed Electrophysiology Catheters (2008), 1 descendant of its own
- K242225: Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (2024), 0 descendants of its own
- K203261: Reprocessed Inquiry Steerable Diagnostic EP Catheter (2021), 0 descendants of its own
- K112232: Reprocessed Electrophysiology Catheters (2011), 0 descendants of its own

## Indications for use
Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

Source page: https://510kreport.com/device/K982232
Methodology: https://510kreport.com/methodology