Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

73 results for "Biosense Webster, Inc."
1–24 of 73
Search insights Median review: 99d Cleared: 100% Top manufacturer: Biosense Webster, Inc. Lead specialty: Cardiovascular
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