Medical Device Manufacturer · US , Irvine , CA

Biosense Webster, Inc.

73 submissions · 73 cleared · Since 1999
73
Total
73
Cleared
0
Denied

Biosense Webster, Inc. — FDA 510(k) Submissions

Biosense Webster, Inc. has submitted 73 FDA 510(k) premarket notifications since 1999, of which 73 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Programmable, Catheter, Electrode Recording, Or Probe, Electrode Recording, Catheter, Intracardiac Mapping, High-density Array, Catheter, Ultrasound, Intravascular, Introducer, Catheter . Use the specialty filter in the sidebar to narrow results.

73 devices
1–25 of 73
CARTO? 3 EP Navigation System V8.4
K252972 · DQK Computer, Diagnostic,... · Cardiovascular
Feb 2026 156d
CARTO? 3 EP Navigation System V9.0 with PIU Plus
K254085 · DQK Computer, Diagnostic,... · Cardiovascular
Jan 2026 31d
CARTO? 3 EP Navigation System V8.1
K252302 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2025 29d
NUVISION? Ultrasound Catheter; NUVISION? NAV Ultrasound Catheter
K241540 · OBJ Catheter, Ultrasound,... · Cardiovascular
Jun 2024 28d
SOUNDSTAR? CRYSTAL Ultrasound Catheter
K240050 · OBJ Catheter, Ultrasound,... · Cardiovascular
Jun 2024 156d
CARTO? 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
K231207 · DQK Computer, Diagnostic,... · Cardiovascular
Sep 2023 133d
PENTARAY? NAV ECO High Density Mapping Catheter, DECANAV? Mapping Catheter, Webster? CS Catheter with Auto ID, Webster? CS Catheter with EZ Steer Technology, Webster? CS Catheter with EZ Steer Technology with Auto ID
K231312 · MTD Catheter, Intracardiac... · Cardiovascular
Jul 2023 66d
CARTO VIZIGO? 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
K231412 · DYB Introducer, Catheter · Cardiovascular
Jul 2023 55d
OPTRELL? Mapping Catheter with TRUEref? Technology
K230253 · MTD Catheter, Intracardiac... · Cardiovascular
Mar 2023 30d
CARTO? 3 EP Navigation System with CARTOSOUND? 4D Version 7.4
K223733 · DQK Computer, Diagnostic,... · Cardiovascular
Feb 2023 65d
NUVISION? NAV Ultrasound Catheter
K223766 · OBJ Catheter, Ultrasound,... · Cardiovascular
Feb 2023 63d
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
K221112 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2022 124d
OPTRELL Mapping Catheter with TRUEref Technology
K211438 · MTD Catheter, Intracardiac... · Cardiovascular
Mar 2022 312d
LASSOSTAR NAV Circular Mapping Catheter
K211219 · DRF Catheter, Electrode... · Cardiovascular
Jan 2022 278d
CARTO 3 EP Navigation System Version 7.2
K213264 · DQK Computer, Diagnostic,... · Cardiovascular
Oct 2021 29d
CARTO? 3 EP Navigation System with Signal Processing Unit
K200484 · DQK Computer, Diagnostic,... · Cardiovascular
Nov 2020 272d
Pentaray Nav eco High-Density Mapping Catheter
K201750 · MTD Catheter, Intracardiac... · Cardiovascular
Aug 2020 41d
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · MTD Catheter, Intracardiac... · Cardiovascular
Jul 2020 249d
LassoStar Circular Mapping Catheter
K193632 · DRF Catheter, Electrode... · Cardiovascular
Jun 2020 186d
CARTO 3 EP Navigation System, Version 7.1 and Accessories
K191660 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2019 29d
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
K173978 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2018 238d
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
K173977 · DQK Computer, Diagnostic,... · Cardiovascular
Jun 2018 167d
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
K180238 · DQK Computer, Diagnostic,... · Cardiovascular
Jun 2018 123d
CARTO 3 EP Navigation System, Version 6.0 and Accessories
K170600 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2017 146d
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
K170997 · DYB Introducer, Catheter · Cardiovascular
Jul 2017 113d
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