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The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image and onical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging. The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.

The CardioOptics Augmentative Cardiac Optical Imaging System is composed of a single-use catheter, accessories, and an Image Acquisition System. The system incorporates infrared light (IR) technology to provide visualization through flowing blood. This submission modifies the indications for use originally cleared in 510(k) No. K050808 to include visualization of the cardiac chambers and great vessels.

The CardioOptics Coronary Sinus Access (CSA™) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a quide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.

The Coronary Sinus Access (CSA™) System provides a catheter and sheath system for providing percutaneous access to the coronary sinus. In addition, the catheter provides visualization to augment the user's ability to locate the coronary sinus for placement of a guide sheath. The system includes a sterile, single use Coronary Sinus Access Kit, which includes a deflecting tip catheter with visualization capability (FLAIR™ CS Catheter), a Guide Sheath Set including a dilator and sheath slitters, and a Sterile Sleeve to drape over the camera pod. The system also includes an Imaging Acquisition System to collect and display video images present in front of the catheter tip.