(243 days)
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.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).