# K053582: Inquiry Afocus II Diagnostic Catheter

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, Inc.
- Decided: Mar 21, 2006 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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
- K101789: Reprocessed Electrophysiology Diagnostic Catheters (2010), 0 descendants of its own

## Indications for use
For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocusTM catheters are for use in mapping atrial regions of the heart.

Source page: https://510kreport.com/device/K053582
Methodology: https://510kreport.com/methodology