# K220796: IntellaMap Orion High Resolution Mapping Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jun 10, 2022 after 84 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: 4 generations back to K011361 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192360: IntellaMap Orion High Resolution Mapping Catheter, Boston Scientific Corporation (2019) Summary page 4.

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

Source page: https://510kreport.com/device/K220796
Methodology: https://510kreport.com/methodology