# K113213: Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Dec 5, 2011 after 34 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002333 (2000). 5 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081258: Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02, Biosense Webster, Inc. (2009) Summary page 1.
- K093376: Lasso Nav Catheter, Biosense Webster, Inc. (2010) Summary page 1.

## Most influential descendants
- K211327: Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters (2022), 0 descendants of its own
- K153006: Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter (2016), 0 descendants of its own
- K153153: Reprocessed Electrophysiology Catheter (2016), 0 descendants of its own
- K130602: Lasso Nav Duo Loop Catheter (2013), 0 descendants of its own

## Recalls of this device
- Jun 19, 2013 · Class II · Z-1617-2013: Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO

## Indications for use
LASSO® 2515 NAV eco Variable Catheter The LASSO® 2515 NAV eco Variable 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. The LASSO® 2515 NAV eco Variable Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.) LASSO® NAV eco Catheter The LASSO® NAV eco 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. The LASSO® NAV eco Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

Source page: https://510kreport.com/device/K113213
Methodology: https://510kreport.com/methodology