Search Results

The HyperForm™ Occlusion Balloon Catheters are indicated for the use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurvsms.

The Occlusion Balloon Catheter is a single lumen balloon catheter that requires the insertion of the 0.010" guidewire to occlude the central lumen to allow inflation of the balloon. When the distal 10 cm platinum coil tip of the guidewire is advanced to or past the catheter tip, it occludes the inflation holes allowing the balloon to inflate through catheter sideholes. The Occlusion Balloon Catheters are marketed as the HyperForm™ and HyperGlide™ Occlusion Balloon Systems which include a quidewire.

The provided text is a 510(k) summary for medical devices, specifically occlusion balloon catheters. It states that no performance data is included in this submission because the devices have not changed. The submission is a "Special 510(k)" which implies minor changes to an already cleared device, allowing for reliance on previous clearances and established performance.

Therefore, the document does not contain information about acceptance criteria or a study proving device performance in the typical sense of a new device requiring such data. It instead relies on demonstrating substantial equivalence to previously cleared predicate devices.

As a result, I cannot populate the table or answer the specific questions about studies, sample sizes, experts, or ground truth based on the provided text. The document explicitly states:

"The Occlusion Balloon Catheter devices have not changed; therefore there is no performance data included in this submission."

Ask a specific question about this device