Biosense Webster Celsius ThermoCool™ DiagnosticAblation Deflectable Tip Catheter

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Johnson & Johnson International (Singapore) Pte Ltd

Class:

Class D medical device

Manufactured by:

Biosense Webster, Inc.

Therapeutic area:

Cardiovascular

Therapeutic indications:

Indicated for use in cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation. CELSIUS® RMT ThermoCool™ Diagnostic/Ablation Steerable Tip Catheter is compatible for use only with the Stereotaxis Magnetic Navigation System.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], For ablation, the catheter is used in conjunction with a RF generator and a dispersive pad. Ethylene oxide sterilised.; Models: Celsius™ THERMO-COOL™ Electrophysiology Catheter B-Type, irrigated tip - (Thermocouple) - D-1189-01-S; DI7TCBLRT; 35Q13R, Celsius™ THERMO-COOL™ Electrophysiology Catheter D-Type, irrigated tip - (Thermocouple) - D-1189-02-S; DI7TCDLRT; 35Q33R, Celsius™ THERMO-COOL™ Electrophysiology Catheter F-Type, irrigated tip - (Thermocouple) - D-1189-03-S; DI7TCFLRT; 35Q53R, Celsius™ THERMO-COOL™ Electrophysiology Catheter J-Type, irrigated tip - (Thermocouple) - D-1189-04-S; DI7TCJLRT; 35Q73R, Celsius™ THERMO-COOL™ Electrophysiology Catheter B-Type, irrigated tip - (Thermocouple) - D-1189-15-S; D7ITCB5L252RT; 35Q17Q, Celsius™ THERMO-COOL™ Electrophysiology Catheter D-Type, irrigated tip - (Thermocouple) - D-1189-16-S; D7ITCD5L252RT; 35Q37Q, Celsius™ THERMO-COOL™ Electrophysiology Catheter F-Type, irrigated tip - (Thermocouple) - D-1189-17-S; D7ITCF5L252RT; 35Q57Q, Celsius™ THERMO-COOL™ Electrophysiology Catheter D-Type, irrigated tip - (Thermistor) - D-1192-02-S; DI7TDLRT; 35R33R, Celsius™ THERMO-COOL™ Electrophysiology Catheter F-Type, irrigated tip - (Thermistor) - D-1192-03-S; DI7TFLRT; 35R53R, Celsius™ THERMO-COOL™ Electrophysiology Catheter B-Type, irrigated tip - (Thermistor) - D-1192-15-S; D7ITB5L252RT; 35R17R, Celsius™ THERMO-COOL™ Electrophysiology Catheter D-Type, irrigated tip - (Thermistor) - D-1192-16-S; D7ITD5L252RT; 35R37R, Celsius™ THERMO-COOL™ Electrophysiology Catheter F-Type, irrigated tip - (Thermistor) - D-1192-17-S; D7ITF5L252RT; 35R57R, Celsius™ RMT ThermoCool Electrophysiology Catheter - D-1302-01-S; CR7TCSIRT; CR7TCSIRT, Interface Cable - D-1170-16-S; C10MR10MSTKS; SW1170-016

Authorization date:

2010-02-10