# K072012: Reflexion Spiral Variable Radius Catheter

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Aug 22, 2007 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
Longest line of descent: 3 generations back to K961924 (1997). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062251: Reflexion Spiral Variable Radius Catheter, Model 402804, St Jude Medical (2006) Summary page 1.

## Most influential descendants
- K080179: Reflexion HD High-Density Mapping Catheter (2009), 1 descendant of its own
- K191170: Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter (2019), 0 descendants of its own
- K101623: Inquiry Afocusii Diagnostic Catheter (2010), 0 descendants of its own
- K090323: Reprocessed Electrophysiology Catheters (2009), 0 descendants of its own

## Indications for use
The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart.

Source page: https://510kreport.com/device/K072012
Methodology: https://510kreport.com/methodology