# K101623: Inquiry Afocusii Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Aug 13, 2010 after 65 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: 5 generations back to K961924 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
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.
- K080179: Reflexion HD High-Density Mapping Catheter, St Jude Medical (2009) Summary page 1.

## Indications for use
The InquiryTm AFocusIITm Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The InquiryTm AFocusIITm Diagnostic Catheters are to be used to map the atrial regions of the heart.

Source page: https://510kreport.com/device/K101623
Methodology: https://510kreport.com/methodology