# K211219: LASSOSTAR NAV Circular Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jan 26, 2022 after 278 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193632: LassoStar Circular Mapping Catheter, Biosense Webster, Inc. (2020) Summary page 4.

## Indications for use
The LASSOSTAR™ NAV Circular Mapping Catheter is indicated for multiple electrode electrophysiology recording and stimulation of the atrial region of the heart. The catheter can be used with a compatible CARTO™ 3 System to provide location information and to create three-dimensional electroanatomic maps. (The catheter is not compatible with CARTO™ 3 Systems prior to Version 7.)

Source page: https://510kreport.com/device/K211219
Methodology: https://510kreport.com/methodology