# K143481: IntellaMap Orion High Resolution Mapping Catheter

- Pathway: 510(k) (Special)
- Applicant: Rhythmia Medical, Inc.
- Decided: Jan 8, 2015 after 31 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 K011361 (2001). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122461: Rhythmia Mapping Catheter, Rhythmia Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K192360: IntellaMap Orion High Resolution Mapping Catheter (2019), 2 descendants of its own
- K220796: IntellaMap Orion High Resolution Mapping Catheter (2022), 0 descendants of its own
- K211662: Reprocessed IntellaMap Orion High Resolution Mapping Catheter (2021), 0 descendants of its own

## Indications for use
The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Source page: https://510kreport.com/device/K143481
Methodology: https://510kreport.com/methodology