(30 days)
The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary vasculature.
When used as part of the system consisting of the CrossBoss™ Catheter, and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
The Stingray LP Catheter facilitates the placement, support and steering of a guidewire into discrete regions of the coronary vasculature through the central guidewire lumen or through one of two side-ports. These side-ports are on opposite sides of the balloon and are identified by radiopaque markers. The side-ports communicate with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the quidewire to exit the Stingray LP Catheter. The Stingray LP Catheter contains a small balloon used for fluoroscopic orientation on the distal tip of a flexible shaft. The distal end of the catheter is hydrophilic coated. The Stingray LP Catheter is compatible with 6F guide catheters with minimum inner diameter of 0.070 in (1.7 mm), and may be used with guidewires ≤0.014 in (0.36 mm).
This document describes a 510(k) premarket notification for the Stingray LP Catheter. It is a submission for a medical device and, as such, does not contain information related to AI/ML or software performance evaluation studies. Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as the provided text does not contain any of these details in the context of an AI/ML device study.
The document focuses on explaining that the device is substantially equivalent to a previously cleared predicate device based on its indications for use, technological characteristics, and non-clinical performance data (bench and biocompatibility testing).
§ 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).