# K192360: IntellaMap Orion High Resolution Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 25, 2019 after 56 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 K011361 (2001). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K143481: IntellaMap Orion High Resolution Mapping Catheter, Rhythmia Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- 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/K192360
Methodology: https://510kreport.com/methodology