(80 days)
Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
The Occlusion Balloon Catheter product line consists of two specific designs – Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters.
Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.
The proposed devices are constructed of a dual lumen catheter shaft to which two luer fittings are attached proximately and a soft compliant balloon is mounted on the distal end of the shaft. The tubing marked BALLOON is the balloon inflation lumen. The tubing marked DISTAL is the central lumen. The central lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium or, in the case of the Berenstein Occlusion Balloon Catheter, coaxial delivery of small catheters or embolic agents.
As are the predicated devices, the proposed devices are provided with 1.25ml syringe. There are no changes to this accessory proposed in this submission
The provided text is related to a Special 510(k) Premarket Notification for an Occlusion Balloon Catheter. This document is a regulatory submission for a medical device and does not contain information about an AI-powered device or a study proving its performance against acceptance criteria in the context of AI.
The document discusses the device's intended use, description, biocompatibility, and substantial equivalence to predicate devices, focusing on physical characteristics and safety for a traditional medical device, not an AI algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided 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).