Cleared Traditional

LASSOSTAR NAV Circular Mapping Catheter

K211219 · Biosense Webster, Inc. · Cardiovascular

Jan 2022

Decision

278d

Days

Class 2

Risk

About This 510(k) Submission

K211219 is an FDA 510(k) clearance for the LASSOSTAR NAV Circular Mapping Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on January 26, 2022, 278 days after receiving the submission on April 23, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K211219 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2021
Decision Date	January 26, 2022
Days to Decision	278 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