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The catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

The Versa-Cath Arterial Catheter is a dual lumen nylon tube with a natural latex balloon attached to a distal end. There are two stopcocks affixed to the proximal end, one for balloon inflation and the other for fluid irrigation and/or aspiration. It will be packaged with a syringe and a stylet. The syringe is a pre-amendment device and the stylet is marketed under 510(k) K832023. The catheter will be available in 5 sizes and 3 lengths.

This document describes a medical device, the Versa-Cath Arterial Catheter, for which a 510(k) premarket notification was filed (K961883). The provided text is a summary of the device description and its substantial equivalence argument, not a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested table and study details because the input does not contain information about acceptance criteria or a study that evaluated the device's performance against specific criteria. The document focuses on describing the device, its intended use, and materials to establish substantial equivalence to predicate devices, which is a regulatory pathway, not a performance study.

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