BIOSENSE WEBSTER, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30133000263013300026BIOSENSE WEBSTER, INC.1Y2026-01-0131 Technology Drive, Suite 200 -- Irvine CA US 92618
30224510733022451073BIOSENSE WEBSTER, INC.1N2026-01-0123 Hubble Drive Irvine CA US 92618
20206382020638BIOSENSE WEBSTER, INC.1Y2020-04-255110 COMMERCE RD. BALDWIN PARK CA US 91706
20290463003113629BIOSENSE WEBSTER, INC.1Y2020-04-2515715 ARROW HWY. IRWINDALE CA US 91706

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
587431452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
587421452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
3083481452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
587421419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
587431419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
3083481419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
587421559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
587431559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
3083481559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
3083481163060217P240006VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)QZI2024-11-06
3083481316897506P210027QDOT MICRO™ SystemOAE2022-11-23
587421165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
587431165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
3083481165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
587431612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
587421612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
3083481612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
587431366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
587421366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
3083481366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
587431148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
587421148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
3083481148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
587431367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
587421367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
3083481367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
587431780546532K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
3083481780546532K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
587421063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
587431063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
3083481063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
587421078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
587431078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
3083481078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
587431942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
587421942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
3083481942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
587421425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
587431425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
3083481425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
587431816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
587421816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
3083481816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
587431079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
587421079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
3083481079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
587431700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
587421700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
3083481700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
587421306939737K892265
587431306939737K892265
3083481306939737K892265
587421718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
587431718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
3083481718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
587421373562806K841802ELECTRODE CATHETER, ORTHOGONAL TYPELDF1984-10-18
587431373562806K841802ELECTRODE CATHETER, ORTHOGONAL TYPELDF1984-10-18
587431836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
587421836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
3083481836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
3083481526307804K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusDQK2026-01-18
3083481196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
3140191196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
3140191889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
3083481889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
3083481999568673K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterOBJ2024-06-28
3083482045780395K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterOBJ2024-06-12
3083481570366164K231312PENTARAY® 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 IDMTD2023-07-10
3083481259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
3140191259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
3083481838273211K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyMTD2023-03-02
3083482007244677K223766NUVISION™ NAV Ultrasound CatheterOBJ2023-02-16
3083481886013154K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4DQK2023-02-16
3083481298566348K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK2022-08-17
3140191298566348K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK2022-08-17
3083481446518845K213264CARTO 3 EP Navigation System Version 7.2DQK2021-10-29
3140191446518845K213264CARTO 3 EP Navigation System Version 7.2DQK2021-10-29
3083481626964321K211438OPTRELL Mapping Catheter with TRUEref TechnologyMTD2022-03-18
3083481795239315K211219LASSOSTAR NAV Circular Mapping CatheterDRF2022-01-26
3083481396086927K201775NuVision ICE CatheterOBJ2021-03-05
3083481457602595K201750Pentaray Nav eco High-Density Mapping CatheterMTD2020-08-06
3083481079351507K200484CARTO® 3 EP Navigation System with Signal Processing UnitDQK2020-11-25
3083481271511203K193632LassoStar Circular Mapping CatheterDRF2020-06-30
3083481124588025K193237Carto Octaray Mapping Catheter with Trueref TechnologyMTD2020-07-31
3083481724992981K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesDQK2019-07-20
3083481272261028K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTDQK2018-06-01
3140191272261028K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTDQK2018-06-01
3083481436245044K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER ModuleDQK2018-08-24
3083481561419386K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleDQK2018-06-14
3140191561419386K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleDQK2018-06-14
587431782306970K170997CARTO VIZIGO 8.5F Bi-Directional Guiding SheathDYB2017-07-25
3083481782306970K170997CARTO VIZIGO 8.5F Bi-Directional Guiding SheathDYB2017-07-25
587431884929606K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesDQK2017-07-25
3083481884929606K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesDQK2017-07-25
3140191884929606K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesDQK2017-07-25
587431294293476K140318SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETEROBJ2014-03-12
3083481294293476K140318SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETEROBJ2014-03-12
587432060908842K133916CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2DQK2014-07-01
587431107305348K132782CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2DQK2014-01-24
587431220189289K130602LASSO NAV DUO LOOP CATHETERDRF2013-08-14
3083481220189289K130602LASSO NAV DUO LOOP CATHETERDRF2013-08-14
587431365944363K123837PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETERMTD2013-03-05
3083481365944363K123837PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETERMTD2013-03-05
587431513882560K120550CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)DQK2012-05-07
587431582213465K120425PENTARAY NAV HIGH-DENSITY MAPPING CATHETERMTD2012-05-24
3083481582213465K120425PENTARAY NAV HIGH-DENSITY MAPPING CATHETERMTD2012-05-24
587431459095215K113213LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2DRF2011-12-05
3083481459095215K113213LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2DRF2011-12-05
587431519836953K112050SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETEROBJ2011-11-18
3083481519836953K112050SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETEROBJ2011-11-18
587431121636626K112007CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2DQK2011-10-05
587432059738201K101991WEBSTER DUO-DECAPOLAR CATHETERDRF2011-05-02
3083482059738201K101991WEBSTER DUO-DECAPOLAR CATHETERDRF2011-05-02
3083481759609951K101345WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,DRF2010-06-22
587431436335805K101138SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12OBJ2010-06-22
3083481436335805K101138SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12OBJ2010-06-22
3083482002058817K093376LASSO NAV CATHETERDRF2010-06-18
587431492436982K092064SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12OBJ2009-08-07
3083481492436982K092064SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12OBJ2009-08-07
587431700768207K091352SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05OBJ2009-12-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRF692022-01-26
DQK302026-02-20
OBJ172024-06-28
MTD122023-07-10
DYB102017-07-25
LPB92006-08-11
OAD62004-11-05
DSA32000-07-21
DYG31985-12-03
LDF21984-10-18

PMA#

200 records. Showing 1-40. Next

PMN#

69 records. Showing 1-40. Next