(194 days)
The ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
Here's a breakdown of the acceptance criteria and study information for the ArteriA Occlusion Balloon, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices (External communicating, blood contact, short duration |
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).