# K031161: Variable Lasso 2515 Circular Mapping Catheter

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Jul 22, 2003 after 99 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002333 (2000). 1 ancestor in all.
9 later devices descend from it; 3 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)
- K002333: Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220, Biosense Webster, Inc. (2000)

## Most influential descendants
- K081258: Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02 (2009), 7 descendants of its own
- 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
- K082023: Reprocessed Electrophysiology Catheters (2008), 1 descendant 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

## Recalls of this device
- Mar 25, 2008 · Not classified · Z-1704-2008: This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be t
- Mar 25, 2008 · Not classified · Z-1703-2008: This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be t

## Indications for use
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording and stimulation only. The LASSO25 15 Variable Circular Mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Source page: https://510kreport.com/device/K031161
Methodology: https://510kreport.com/methodology