(72 days)
The St. Jude Medical CPS Aim SL Slittable inner catheter intended use is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including guidewires. In addition, the inner catheters can work with outer guide catheters as a system.
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I am sorry, but the provided text from K082932 is a 510(k) clearance letter for the CPS Aim SL Slittable Inner Catheter. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device for marketing purposes.
It does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics, sample sizes, expert involvement, or AI-specific evaluations.
Therefore, I cannot provide the requested information based on the input text.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).