# K081258: Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jan 6, 2009 after 249 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: 2 generations back to K002333 (2000). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031161: Variable Lasso 2515 Circular Mapping Catheter, Biosense Webster, Inc. (2003) Summary page 1.
- K954390: Cordis Wester Star Catheter, Cordis Webster, Inc. (1995) Summary page 1.

## Most influential descendants
- K093376: Lasso Nav Catheter (2010), 5 descendants of its own
- K113213: Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2 (2011), 4 descendants of its own
- 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

## Indications for use
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart. The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.

Source page: https://510kreport.com/device/K081258
Methodology: https://510kreport.com/methodology