ClearanceBrief
Product code LPB ยท Class 3

Cardiac Ablation Percutaneous Catheter

0510(k)s in 12 months (0 all time)
0recalls in 12 months (21 all time)
0recalls that name a 510(k)
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Top companies in LPB

DateFirm and productCodeLinked 510(k)
Sep 6, 2017Biosense Webster, Inc.
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Terminated
LPBNone listed
Sep 6, 2017Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Terminated
LPBNone listed
Sep 6, 2017Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
Terminated
LPBNone listed
Sep 6, 2017Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Terminated
LPBNone listed
Sep 6, 2017Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Terminated
LPBNone listed
Jun 14, 2017Biosense Webster, Inc.
SMARTABLATE RF System Generator
Terminated
LPBNone listed
Sep 17, 2015Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Terminated
LPBNone listed
Oct 27, 2014Biosense Webster, Inc.
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Terminated
LPBNone listed
Sep 16, 2011St Jude Medical
7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ablation electrode at
Terminated
LPBNone listed
Sep 16, 2011St Jude Medical
7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725, Description: 1304-7-25-L-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ablation electrode at
Terminated
LPBNone listed
Sep 16, 2011St Jude Medical
7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: 1304-7-25-M-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ablation electrode at
Terminated
LPBNone listed
Sep 12, 2011Biosense Webster, Inc.
STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during card
Terminated
LPBNone listed
Jan 27, 2011Boston Scientific Corp
RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000xp Cardiac Ablation
Terminated
LPBNone listed
Nov 1, 2010Boston Scientific Corporation
Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Et
Terminated
LPBNone listed
Mar 17, 2010Boston Scientific Corp
CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific C
Terminated
LPBNone listed
Nov 19, 2009BioSense Webster, Inc.
Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02
Terminated
LPBNone listed
Nov 19, 2009BioSense Webster, Inc.
Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02
Terminated
LPBNone listed
Jan 14, 2009Boston Scientific Corp
RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and dis
Terminated
LPBNone listed
Sep 20, 2008St. Jude Medical Cardiovascular Division
The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-
Terminated
LPBNone listed
Aug 29, 2006CryoCath Technologies Inc.
7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
Terminated
LPBNone listed
Oct 15, 2005Biosense Webster, Inc.
Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17T
Terminated
LPBNone listed

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