Profile: Biosense Webster (Israel), Ltd. provides various cardiac mapping systems and image guided neurosurgery navigation systems.
FDA Registration Number: 3008203003
US Agent: Vadim Kastin, Sr. Dir. Quality & Compliance / Biosense Webster, Inc.
Phone: +1-(909)-839-8827 Fax: +1-(909)-839-7207 E-Mail:
3 Products/Services (Click for related suppliers)
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• Electrode Recording Catheter (FDA Code: DRF / 870.1220) An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations. |
• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560) A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. |
• Programmable Diagnostic Computer (FDA Code: DQK / 870.1425) A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs. |