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The Surgica Corporation MaxiStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

Surgica Corporation MaxiStat™ Polyvinyl Alcohol (PVA) foam embolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyvinyl Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.

The provided text is a 510(k) summary for the Surgica Corporation MaxiStat™ Polyvinyl Alcohol Foam Embolization Particles. It explicitly states:

"Clinical Tests: None"

This means that no clinical studies were performed to establish acceptance criteria or to demonstrate that the device meets those criteria. The submission relies on substantial equivalence to a predicate device. Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because such a study was not conducted as part of this 510(k) submission.

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