# K153153: Reprocessed Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Mar 14, 2016 after 133 days
- Product code: NLH (Catheter, Recording, Electrode, 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: 5 generations back to K002333 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113213: Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2, Biosense Webster, Inc. (2011) Summary page 5.
- K093376: Lasso Nav Catheter, Biosense Webster, Inc. (2010) Summary page 5.
- K081258: Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02, Biosense Webster, Inc. (2009) Summary page 5.

## Indications for use
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheters are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed LASSO NAV and Reprocessed LASSO 2515 NAV eco Variable Catheters provide location information when used with compatible CARTO 3 EP Navigation Systems. (These catheters are not compatible with CARTO 3 EP Navigation Systems prior to Version 2.3.)

Source page: https://510kreport.com/device/K153153
Methodology: https://510kreport.com/methodology