Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

73 results for "Biosense Webster, Inc."
1–24 of 73
Cleared Feb 20, 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · DQK
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Jan 18, 2026
CARTO™ 3 EP Navigation System V9.0 with PIU Plus
K254085 · DQK
Biosense Webster, Inc.
Cardiovascular · 31d
Cleared Aug 22, 2025
CARTO™ 3 EP Navigation System V8.1
K252302 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Jun 28, 2024
NUVISION™ Ultrasound Catheter
K241540 · OBJ
Biosense Webster, Inc.
Cardiovascular · 28d
Cleared Jun 12, 2024
SOUNDSTAR™ CRYSTAL Ultrasound Catheter
K240050 · OBJ
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Sep 07, 2023
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
K231207 · DQK
Biosense Webster, Inc.
Cardiovascular · 133d
Cleared Jul 10, 2023
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S,...
K231412 · DYB
Biosense Webster, Inc.
Cardiovascular · 55d
Cleared Jul 10, 2023
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter,...
K231312 · MTD
Biosense Webster, Inc.
Cardiovascular · 66d
Cleared Mar 02, 2023
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · MTD
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Feb 16, 2023
NUVISION™ NAV Ultrasound Catheter
K223766 · OBJ
Biosense Webster, Inc.
Cardiovascular · 63d
Cleared Feb 16, 2023
CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
K223733 · DQK
Biosense Webster, Inc.
Cardiovascular · 65d
Cleared Aug 17, 2022
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
K221112 · DQK
Biosense Webster, Inc.
Cardiovascular · 124d
Cleared Mar 18, 2022
OPTRELL Mapping Catheter with TRUEref Technology
K211438 · MTD
Biosense Webster, Inc.
Cardiovascular · 312d
Cleared Jan 26, 2022
LASSOSTAR NAV Circular Mapping Catheter
K211219 · DRF
Biosense Webster, Inc.
Cardiovascular · 278d
Cleared Oct 29, 2021
CARTO 3 EP Navigation System Version 7.2
K213264 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Nov 25, 2020
CARTO® 3 EP Navigation System with Signal Processing Unit
K200484 · DQK
Biosense Webster, Inc.
Cardiovascular · 272d
Cleared Aug 06, 2020
Pentaray Nav eco High-Density Mapping Catheter
K201750 · MTD
Biosense Webster, Inc.
Cardiovascular · 41d
Cleared Jul 31, 2020
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · MTD
Biosense Webster, Inc.
Cardiovascular · 249d
Cleared Jun 30, 2020
LassoStar Circular Mapping Catheter
K193632 · DRF
Biosense Webster, Inc.
Cardiovascular · 186d
Cleared Jul 20, 2019
CARTO 3 EP Navigation System, Version 7.1 and Accessories
K191660 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Aug 24, 2018
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER...
K173978 · DQK
Biosense Webster, Inc.
Cardiovascular · 238d
Cleared Jun 14, 2018
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP...
K173977 · DQK
Biosense Webster, Inc.
Cardiovascular · 167d
Cleared Jun 01, 2018
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
K180238 · DQK
Biosense Webster, Inc.
Cardiovascular · 123d
Cleared Jul 25, 2017
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
K170997 · DYB
Biosense Webster, Inc.
Cardiovascular · 113d