# K212776: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Dec 20, 2021 after 110 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: 7 generations back to K983171 (1999). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200212: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, Innovative Health, LLC (2020) Summary page 5.
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled, St. Jude Medical, Inc. (2018) Summary page 5.

## Indications for use
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Source page: https://510kreport.com/device/K212776
Methodology: https://510kreport.com/methodology