(65 days)
The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device (Occlusion Balloon Catheter, Model Venos™). It does not contain information about acceptance criteria and a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from this document. The letter only states that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not detail the specific performance metrics or studies used to demonstrate that equivalence.
§ 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).