# K191880: Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Dec 11, 2019 after 149 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 K102588 (2011). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162892: Achieve Advance Mapping Catheter, Medtronic, Inc. (2016) Summary page 5.

## Indications for use
The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.

Source page: https://510kreport.com/device/K191880
Methodology: https://510kreport.com/methodology