# K193632: LassoStar Circular Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jun 30, 2020 after 186 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: 1 generation back to K002333 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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) Summary page 4.

## Most influential descendants
- K211219: LASSOSTAR NAV Circular Mapping Catheter (2022), 0 descendants of its own

## Indications for use
The LassoStar™ Circular Mapping Catheter is indicated for multiple electrode electrophysiological recording and stimulation of the atrial region of the heart. The catheter is designed to obtain electrograms in the atrial region of the heart.

Source page: https://510kreport.com/device/K193632
Methodology: https://510kreport.com/methodology