Cleared Traditional

LassoStar Circular Mapping Catheter

K193632 · Biosense Webster, Inc. · Cardiovascular

Jun 2020

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K193632 is an FDA 510(k) clearance for the LassoStar Circular Mapping Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on June 30, 2020, 186 days after receiving the submission on December 27, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K193632 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2019
Decision Date	June 30, 2020
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1220