# K060757: Inquiry Optima Plus Steerable Electrophysiology Catheter

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, Inc.
- Decided: Apr 19, 2006 after 29 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
Longest line of descent: 2 generations back to K961924 (1997). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter, Irvine Biomedical, Inc. (2004) Summary page 1.

## Most influential descendants
- K160421: Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter (2016), 0 descendants of its own
- K112232: Reprocessed Electrophysiology Catheters (2011), 0 descendants of its own
- K101789: Reprocessed Electrophysiology Diagnostic Catheters (2010), 0 descendants of its own

## Indications for use
The Inquiry Optima Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima catheters are to be used to map the atrial regions of the heart.

Source page: https://510kreport.com/device/K060757
Methodology: https://510kreport.com/methodology