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The GORE Balloon Sheath is indicated for temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices into selected blood vessels in the peripheral and neurovascular systems.

The GORE Balloon Sheath consists of a dual lumen catheter shaft with a compliant balloon mounted at the distal-most tip of the shaft. The GORE Balloon Sheath is provided with compatible dilator which facilitates a gradual transition from the guide wire diameter to the sheath internal diameter. The first lumen acts as the inflation lumen while the second lumen acts as the working channel, accommodating diagnostic and therapeutic interventional devices. The sheath hub consists of four ports. The first port ("balloon inflation port") has a female luer thread, allowing assembly of a syringe and stopcock for balloon inflation. The second port ("fluid port") has a flexible tubing extension, which permits access to the working channel to subsequently allows fluid (e.g. contrast agent) injections and / or blood aspiration. The third port ("auxiliary port") allows side access to the working channel to introduce interventional devices. The fourth port ("main port") provides linear access to the working channel, functioning primarily as the delivery port for diagnostic and therapeutic devices.

The provided document is a 510(k) summary for the GORE Balloon Sheath and Dilator, focusing on establishing substantial equivalence to predicate devices for regulatory clearance. It does not contain information about a study proving the device meets specific performance acceptance criteria in the manner of a clinical trial or algorithm performance study.

Instead, the "Testing" section describes conformity to established standards for medical devices.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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