Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
Johnson & Johnson International (Singapore) Pte Ltd
Class D medical device
Biosense Webster, Inc.
Cardiovascular
Indicated for use in cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation. Provides location information when used with compaible CARTO EP Navigation System. NaviStar™ RMT ThermoCool™ Diagostic/Ablation Steerable Tip Catheter is compatible for use only with the Stereotaxis Magnetic Navigation System.
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: Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1197-14-S; NI75TCBH; 34H-17M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1197-15-S; NI75TCCH; 34H-27M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1197-16-S; NI75TCDH; 34H-37M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1197-17-S; NI75TCFH; 34H-57M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1197-18-S; NI75TCJH; 34H-J7M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1208-05-S; NI75TBH; 34G-17M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1208-06-S; NI75TCH; 34G-27M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1208-07-S; NI75TDH; 34G-37M, Navi-Star™ Thermo-cool™ Electroplysiology Catheter - D-1208-08-S; NI75TFH; 34G-57M, NaviStar® RMT ThermoCool® Electrophysiology Catheter - D-1266-01-S; NR7TCSIY; NR7TCSIY, Interface Cable - D-1170-16-S; C10MR10MSTKS; SW1170-016, Interface Cable - C5MHNAVMHS; 39E58M, Carto® 3 System Interface Cable (10 Ft (305cm), 34-Pin Red to 25-Pin Red) - D-1286-04-S; CR3425CT
2010-02-10