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The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The Pronto V3 extraction catheter is a dual lumen polymeric catheter that is reinforced with a braided metallic mid-layer. The Pronto V3 includes related accessories. The extraction lumen allows for the aspiration and removal of embolic material (thrombus/debris) by using the included syringe, extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen that facilitates atraumatic advancement of the catheter into the blood vessel and maximizes the extraction of emboli/thrombi through the extraction lumen. Near the catheter's distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter has a monorail design. It has a flexible distal region and stiffness along the shaft and proximal region. The proximal end of the catheter has a standard luer adapter that attaches to the included extension line, stopcock, and syringe. The distal region of the catheter has a lubricious hydrophilic coating that allows for ease of catheter advancement. The catheter has an approximate outer diameter of 0.065 inches, allowing for delivery through standard 6F guide catheters. The guide wire lumen of the catheter accommodates guide wires that are

The provided text is a 510(k) summary for the Pronto™ V3 Extraction Catheter, focusing on its substantial equivalence to a previously marketed device. This type of submission relies on demonstrating similarity to an existing device rather than providing de novo clinical study data to prove performance against specific acceptance criteria.

Therefore, the document does not contain any information regarding acceptance criteria, device performance metrics, clinical study design, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The section "Summary of Testing" explicitly states: "No additional testing was required to support this indication." This sentence indicates that the 510(k) submission primarily relies on demonstrating that the new device is substantially equivalent to a predicate device, and thus, new performance data or clinical trials were not conducted or submitted for this specific approval.

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