Biosense Webster, Inc.
FDA 510(k) medical device clearances.
Top product codes for Biosense Webster, Inc.
Recent clearances by Biosense Webster, Inc.
- K252972 — CARTO 3 EP Navigation System V8.4
- K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus
- K252302 — CARTO 3 EP Navigation System V8.1
- K241540 — NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter
- K240050 — SOUNDSTAR CRYSTAL Ultrasound Catheter
- K231207 — CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
- K231312 — 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
- K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
- K230253 — OPTRELL Mapping Catheter with TRUEref Technology
- K223733 — CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4
- K223766 — NUVISION NAV Ultrasound Catheter
- K221112 — CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
- K211438 — OPTRELL Mapping Catheter with TRUEref Technology
- K211219 — LASSOSTAR NAV Circular Mapping Catheter
- K213264 — CARTO 3 EP Navigation System Version 7.2
- K200484 — CARTO® 3 EP Navigation System with Signal Processing Unit
- K201750 — Pentaray Nav eco High-Density Mapping Catheter
- K193237 — Carto Octaray Mapping Catheter with Trueref Technology
- K193632 — LassoStar Circular Mapping Catheter
- K191660 — CARTO 3 EP Navigation System, Version 7.1 and Accessories
- K173978 — CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
- K173977 — CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
- K180238 — CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
- K170600 — CARTO 3 EP Navigation System, Version 6.0 and Accessories
- K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
- K133916 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
- K132782 — CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
- K130602 — LASSO NAV DUO LOOP CATHETER
- K123837 — PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
- K120425 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
- K120550 — CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
- K113213 — LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
- K112050 — SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
- K112007 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
- K101991 — WEBSTER DUO-DECAPOLAR CATHETER
- K103746 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
- K101138 — SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
- K101345 — WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
- K093376 — LASSO NAV CATHETER
- K093566 — CARTO XP EP NAVIGATION SYSTEM, VERSION 10
- K091352 — SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
- K093455 — CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
- K090017 — CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
- K091789 — CARTO RMT EP NAVIGATION SYSTEM V8
- K090898 — CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
- K092064 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
- K090120 — REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
- K081258 — VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
- K080425 — CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
- K072202 — CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
- K070242 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
- K070240 — CARTO XP EP NAVIGATION SYSTEM, VERSION 9
- K061463 — ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
- K061468 — REFSTAR EXTERNAL REFERENCE PATCH
- K060047 — CARTO RMT EP NAVIGATION SYSTEM V8
- K053194 — NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
- K042681 — CARTO RMT EP NAVIGATION SYSTEM
- K042998 — REFSTAR RMT EXTERNAL REFERENCE PATCH
- K052083 — NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
- K050877 — CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
- K050217 — FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
- K042999 — CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
- K031161 — VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
- K020863 — CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
- K013083 — CARTO XP EP NAVIGATION SYSTEM
- K002333 — BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
- K001390 — BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
- K001139 — PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
- K000190 — MODIFICATION TO CARTO EP NAVIGATION SYSTEM
- K000248 — CARTO EP NAVIGATION SYSTEM
- K000332 — NOGA CARDIAC NAVIGATION SYSTEM
- K993729 — MODIFICATION TO CARTO EP NAVIGATION SYSTEM
- K992968 — CARTO EP NAVIGATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.