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Biosense Webster, Inc.

557 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
TRUPULSE™ Generator (P240006/S012)Biosense Webster, Inc.2025-12-23
nGEN™ Pump (P990071/S068)Biosense Webster, Inc.2025-12-23
SMARTABLATE™ System Interface Cable (D-1303-02-S) (P990071/S067)Biosense Webster, Inc.2025-09-15
VARIPULSE™ Catheter (P240006/S011)Biosense Webster, Inc.2025-09-10
VARIPULSE™ Platform; VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump (P240006/S010)Biosense Webster, Inc.2025-08-07
VARIPULSE™ Platform (P240006/S009)Biosense Webster, Inc.2025-07-23
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006/S007)Biosense Webster, Inc.2025-06-26
VARIPULSE Bi-Directional Catheter (P240006/S008)Biosense Webster, Inc.2025-06-05
VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; nGEN (TM) Pump (P240006/S001)Biosense Webster, Inc.2025-05-09
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006/S006)Biosense Webster, Inc.2025-04-16
QDOT MICRO™ System (P210027/S012)Biosense Webster, Inc.2025-04-08
STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S066)Biosense Webster, Inc.2025-03-28
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006/S004)Biosense Webster, Inc.2025-03-26
Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P950005/S088)Biosense Webster, Inc.2025-02-26
Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P030031/S138)Biosense Webster, Inc.2025-02-26
Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P010068/S074)Biosense Webster, Inc.2025-02-26
SmartAblate System Interface Cable (P990071/S065)Biosense Webster, Inc.2025-02-26
TX eco EXT Cable (P210027/S014)Biosense Webster, Inc.2025-02-26
Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P240006/S002)Biosense Webster, Inc.2025-02-26
Thermocool Deflectable Diagnostic/ Ablation Catheter (P040036/S100)Biosense Webster, Inc.2025-02-25
NAVISTAR DS Electrophysiology Catheter (P010068/S075)Biosense Webster, Inc.2025-02-25
QDOT MICRO System (P210027/S015)Biosense Webster, Inc.2025-02-25
Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe (P030031/S139)Biosense Webster, Inc.2025-02-25
NAVISTAR Electrophysiology Catheter (P990025/S074)Biosense Webster, Inc.2025-02-25
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006/S003)Biosense Webster, Inc.2025-02-18
SMARTABLATE™ Irrigation Tubing Set (P990071/S063)Biosense Webster, Inc.2025-02-11
nGEN™ Pump (P990071/S064)Biosense Webster, Inc.2025-01-22
Thermocool SmartTouch Bi-Directional Navigation Catheter, Thermocool SmartTouch Uni-Directional Navigation Catheter (P040036/S099)Biosense Webster, Inc.2024-11-20
Theermocool SF NAV Bi-Directional Catheter (P990071/S062)Biosense Webster, Inc.2024-11-20
EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter (P010068/S073)Biosense Webster, Inc.2024-11-20
QDOT Micro Uni-Directional Navigation Catheter, QDOT Micro Bi-Directional Navigation Catheter (P210027/S013)Biosense Webster, Inc.2024-11-20
NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T (P030031/S137)Biosense Webster, Inc.2024-11-20
NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol (P990025/S073)Biosense Webster, Inc.2024-11-20
nMARQ Catheter Interference Cable (P950005/S087)Biosense Webster, Inc.2024-11-15
nMARQ Catheter Interference Cable (P030031/S135)Biosense Webster, Inc.2024-11-15
Smartablate System Interface Cable (P990071/S060)Biosense Webster, Inc.2024-11-15
nMARQ Catheter Interference Cable (P990025/S072)Biosense Webster, Inc.2024-11-15
nMARQ Catheter Interference Cable (P010068/S072)Biosense Webster, Inc.2024-11-15
nMARQ Catheter Interference Cable (P040036/S097)Biosense Webster, Inc.2024-11-15
TX eco Extension Cable (P210027/S008)Biosense Webster, Inc.2024-11-15
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006)Biosense Webster, Inc.2024-11-06
nGEN™ Pump (P990071/S061)Biosense Webster, Inc.2024-10-30
QDOT MICRO Uni-Directional Navigation Catheter (P210027/S011)Biosense Webster, Inc.2024-07-16
QDOT MICRO Navigation Catheter (P210027/S009)Biosense Webster, Inc.2024-05-27
THERMOCOOL SMARTTOUCH SF Catheter (P040036/S098)Biosense Webster, Inc.2024-05-24
THERMOCOOL SMARTTOUCH Catheter (P030031/S136)Biosense Webster, Inc.2024-05-24
QDOT MICRO Uni-Directional Navigation Catheter, QDOT MICRO Bi-Directional Navigation Catheter (P210027/S005)Biosense Webster, Inc.2024-05-22
QDOT Micro Navigation Catheter (P210027/S007)Biosense Webster, Inc.2024-03-25
QDOT MICRO™ System (P210027/S006)Biosense Webster, Inc.2024-03-25
SmartAblate Irrigation Tubing Set (P990071/S059)Biosense Webster, Inc.2024-02-19
SmartAblate™ Irrigation Tubing Set (SAT001) (P990071/S058)Biosense Webster, Inc.2024-02-16
Thermocool Smarttouch SF (P030031/S134)Biosense Webster, Inc.2023-09-28
Thermocool Smarttouch (P040036/S096)Biosense Webster, Inc.2023-09-28
QDOT MICRO™ System (P210027/S004)Biosense Webster, Inc.2023-09-19
THERMOCOOL SMARTTOUCH® SF (P040036/S091)Biosense Webster, Inc.2023-08-03
THERMOCOOL SMARTTOUCH® (P030031/S129)Biosense Webster, Inc.2023-08-03
QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable (P210027/S002)Biosense Webster, Inc.2023-07-20
THERMOCOOL SMARTTOUCH® Catheter (P030031/S126)Biosense Webster, Inc.2023-07-18
Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables (P010068/S071)Biosense Webster, Inc.2023-06-12
Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, Deflectable Diagnostic/Ablation Catheter, Celsius Catheter, (P950005/S086)Biosense Webster, Inc.2023-06-12
NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables (P990025/S071)Biosense Webster, Inc.2023-06-12
Interface Cables (P990071/S057)Biosense Webster, Inc.2023-06-12
ThermoCool SmartTouch Catheters, EZ Steer ThermoCool Nav Catheter, Celsius RMT ThermoCool Catheter, ThermoCool SF NAV Ca (P030031/S133)Biosense Webster, Inc.2023-06-12
EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoCool Catheter, ThermoCool SmartTouch Catheters (P040036/S095)Biosense Webster, Inc.2023-06-12
QDOT MICRO Catheter, Interface Cables (P210027/S003)Biosense Webster, Inc.2023-06-12
Thermocool Smarttouch SF (P030031/S132)Biosense Webster, Inc.2023-05-03
Thermocool Smarttouch (P040036/S094)Biosense Webster, Inc.2023-05-03
Thermocool Smarttouch Bi-directional Catheter, Thermocool Smarttouch Bi-directional Catheter (P040036/S093)Biosense Webster, Inc.2023-03-10
Thermocool Smarttouch SF Uni-directional Catheter, Thermocool Smarttouch SF Uni-directional Catheter (P030031/S131)Biosense Webster, Inc.2023-03-10
QDOT MICRO™ System, nGEN™ Generator (P210027/S001)Biosense Webster, Inc.2023-02-24
SmartAblate™ Irrigation Tubing Set (P990071/S055)Biosense Webster, Inc.2023-01-24
QDOT MICRO™ System (P210027)Biosense Webster, Inc.2022-11-23
Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter (P030031/S128)Biosense Webster, Inc.2022-09-30
Celsius FLTRR, EZ Steer Nav DS Catheter (P010068/S070)Biosense Webster, Inc.2022-09-30
NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter, (P990025/S070)Biosense Webster, Inc.2022-09-30
Biosense Webster Cables (P990071/S056)Biosense Webster, Inc.2022-09-30
Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St (P950005/S085)Biosense Webster, Inc.2022-09-30
ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV (P040036/S090)Biosense Webster, Inc.2022-09-30
CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR (P030031/S127)Biosense Webster, Inc.2022-09-09
CELSIUS (P950005/S084)Biosense Webster, Inc.2022-09-09
NAVISTAR (P990025/S069)Biosense Webster, Inc.2022-09-09
8mm Dual Sensor (DS) Catheters (P010068/S069)Biosense Webster, Inc.2022-09-09
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) (P040036/S089)Biosense Webster, Inc.2022-09-09
SmartAblate Irrigation Tubing Set and nGEN Pump (P990071/S054)Biosense Webster, Inc.2022-06-08
SmartAblate Irrigation Tubing Set (P990071/S053)Biosense Webster, Inc.2022-03-15
Dual Sensor (DS) Catheters (P010068/S067)Biosense Webster, Inc.2022-03-08
CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOU (P030031/S122)Biosense Webster, Inc.2022-03-08
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (P040036/S084)Biosense Webster, Inc.2022-03-08
nGEN Pump (P990071/S051)Biosense Webster, Inc.2022-03-08
NAVISTAR (P990025/S067)Biosense Webster, Inc.2022-03-08
CELSIUS (P950005/S082)Biosense Webster, Inc.2022-03-08
ThermoCool SmartTouch (P030031/S125)Biosense Webster, Inc.2022-02-01
ThermoCool SmartTouch SF (P040036/S087)Biosense Webster, Inc.2022-02-01
SmartAblate Irrigation Tubing Set (P990071/S047)Biosense Webster, Inc.2021-12-23
VISITAG SURPOINT External Processing Unit (EPU) (P030031/S110)Biosense Webster, Inc.2021-11-12
Stockert SMARTABLATE System (P990071/S046)Biosense Webster, Inc.2021-09-23
NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER and THERMOCOOL SMARTTOUCH (P040036/S082)Biosense Webster, Inc.2021-09-22
Biosense Webster Cables (P990071/S052)Biosense Webster, Inc.2021-09-22
Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S124)Biosense Webster, Inc.2021-09-22
CELSIUS and EZ STEER (P990025/S065)Biosense Webster, Inc.2021-09-22
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