Biosense Webster (Israel), Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30082030033008203003Biosense Webster (Israel), Ltd.1N2026-01-014 Hatnufa Street Yokneam Northern IL 2066717

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1128591526307804K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusDQK2026-01-18
1128591196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
1128591889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
1128591259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
1128591886013154K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4DQK2023-02-16
1128591298566348K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK2022-08-17
1128591446518845K213264CARTO 3 EP Navigation System Version 7.2DQK2021-10-29
1128591079351507K200484CARTO® 3 EP Navigation System with Signal Processing UnitDQK2020-11-25
1128591724992981K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesDQK2019-07-20
1128591272261028K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTDQK2018-06-01
1128591436245044K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER ModuleDQK2018-08-24
1128591561419386K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleDQK2018-06-14
1128591884929606K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesDQK2017-07-25
1128591641177371K161701CARTO ENT SystemPGW2016-10-24
1128592060908842K133916CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2DQK2014-07-01
1128591107305348K132782CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2DQK2014-01-24
1128591513882560K120550CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)DQK2012-05-07
1128591121636626K112007CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2DQK2011-10-05
1128591609714738K093566CARTO XP EP NAVIGATION SYSTEM, VERSION 10DQK2010-06-18
1128592029830811K093455CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIESDQK2009-12-04
1128592041615821K091789CARTO RMT EP NAVIGATION SYSTEM V8DQK2009-10-01
1128591904873114K090017CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIESDQK2009-10-13
1128591744622052K072202CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)DQK2007-11-19
1128592031747537K053194NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWAREDQK2006-03-09
1128591641177371
1128591661488615
1128591889393595
1128592013711680

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQK242026-02-20
PGW12016-10-24