# K130602: Lasso Nav Duo Loop Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Aug 14, 2013 after 160 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: 5 generations back to K002333 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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)
- K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04,, Biosense Webster, Inc. (2010) Summary page 1.

## Recalls of this device
- Feb 25, 2015 · Class II · Z-1242-2015: Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.

## Indications for use
The LASSO® NAV Duo Loop 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 Duo Loop 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 3.2.)

Source page: https://510kreport.com/device/K130602
Methodology: https://510kreport.com/methodology