Search Results

The Acist PLUS 4™ Angiographic Catheter is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature.

The Acist PLUS 4TM Angiographic Catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system. It is a single-lumen catheter manufactured primarily from a radiopaque plastic tube that has an encapsulated stainless steel wire braid to provide strength for injection pressures up to 8275 kPa. The proximal end of the device incorporates a strain relief with a female plastic Luer hub for injection to the injection source. The stem and tip sections are radiopaque and are permanently formed to a variety of shapes to facilitate use in various parts of the patient's vasculature. The non-tapered soft distal tip has end and multiple side-holes to balance the injection force and stabilize tip position. The device is packaged in a Tyvek-to-poly pouch, sterilized by a validated Ethylene Oxide sterilization cycle, and sold for single use only within a 24-month shelf life.

I am sorry, but the provided text does not contain information about the acceptance criteria or any study details that would allow me to populate the requested table and answer the questions. The document is primarily a 510(k) summary for a medical device (Acist PLUS 4TM Angiographic Catheter), outlining its description, classification, and indications for use, along with the FDA's clearance letter. It does not include performance data or studies.

Ask a specific question about this device