(28 days)
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh. This submission modifies the current UnBalloon Non-Occlusive Modeling Catheter by expanding the product family line with additional nitinol mesh cage sizes and catheter lengths.
This medical device is a modeling catheter used in conjunction with self-expanding endoprostheses in large diameter vessels. The provided text contains information about its acceptance criteria and the studies conducted.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Radial outward force meets specification | Completed (implies meeting specifications) |
| Apposition Length meets specification | Completed (implies meeting specifications) |
| Simulated Anatomical Use successful | Completed (implies successful performance) |
| Biocompatibility (ISO 10993 guidelines) | All blood contact portions passed for |
§ 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).