# K080179: Reflexion HD High-Density Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Jan 7, 2009 after 349 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961924 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K072012: Reflexion Spiral Variable Radius Catheter, St Jude Medical (2007)

## Cited in the summary but kept off the family tree
- K020251: Paragon Infusion System, I-Flow Corp. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K101623: Inquiry Afocusii Diagnostic Catheter (2010), 0 descendants of its own

## Recalls of this device
- Oct 27, 2010 · Not classified · Z-1291-2011: Potential for out of specification star grind teeth.

## Indications for use
The Reflexion HD High-Density Mapping Catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion HD High-Density Mapping Catheter is to be used to map the atrial regions of the heart.

Source page: https://510kreport.com/device/K080179
Methodology: https://510kreport.com/methodology