# K211662: Reprocessed IntellaMap Orion High Resolution Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Nov 18, 2021 after 170 days
- Product code: NLG (Catheter, Intracardiac Mapping, High-Density, Reprocessed)
- 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 5.

## Indications for use
The Reprocessed 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/K211662
Methodology: https://510kreport.com/methodology