Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
Sterilmed, Inc.The Reprocessed AcuNav CRYSTAL and SOUNDSTAR CRYSTAL Ultrasound Catheters are sterile, single-use catheters designed for intracardiac imaging and visualization of cardiac and great vessel anatomy using ultrasound. They are compatible with specific versions of CARTO 3 EP Navigation Systems and aid clinicians by providing real-time imaging and location information during cardiac interventional procedures, improving guidance and safety.
Intended Use
The catheters are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, visualization of other devices in the heart, and provide location information when used with compatible CARTO 3 EP Navigation Systems.
Technology
Sterile, single use disposable imaging catheter with ultrasound transducer providing 2-D imaging and a 3-D location sensor, controlled by a steering mechanism for image plane orientation. Compatible with specific CARTO 3 System versions for navigation and imaging.
Performance
The catheters have undergone biocompatibility, cleanliness, sterilization, packaging, shelf life, electrical, electromagnetic, mechanical safety testing, and comply with relevant ISO and ANSI/AAMI standards. Performance testing shows the devices perform as originally intended.
Predicate Devices
No predicate devices specified
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