Search Results

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

The Acist 4 French 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 1200 psi / 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 radiopague 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 angled 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.

The provided text focuses on the 510(k) summary and FDA clearance letter for the Acist 4 French Angiographic Catheter. It outlines the device's description, intended use, classification, and predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested table or details about a study for this specific device based on the given input. The document is primarily a regulatory filing and approval, not a scientific study report.

Ask a specific question about this device