(560 days)
The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.
The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax and the distal tip balloon is made from latex.
This document does not contain information about a study proving that a device meets acceptance criteria, an AI/ML device, or a standalone algorithm.
The document is a 510(k) summary for the Percu-Pro™ Messenger Balloon Catheter, which is a physical medical device (a catheter). The summary details its design, intended use, and comparison to predicate devices to establish substantial equivalence, rather than providing performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI system.
Therefore, I cannot provide the requested information.
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).