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The Export Aspiration Catheter is indicated for:

• · Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
• · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.

The Export Catheter is a dual lumen catheter for use as a general embolectomy catheter. The main (continuous) lumen of the catheter is the aspiration/infusion lumen while the smaller of the lumens is the guidewire lumen. The size of the wire lumen is sized so that the Export catheter may run over a 0.14-inch guidewire smoothly. Also, the wire lumen is designed as a single operator lumen, as such it is only present on a small section of the distal end of the catheter. The larger sized lumen is the aspiration lumen. An aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.

I am sorry, but based on the limited information provided in the given text, I cannot generate a comprehensive response to your request. The provided text primarily consists of FDA correspondence regarding the "Export Aspiration Catheter," detailing its classification, intended use, and substantial equivalence to a predicate device.

The document does not contain the acceptance criteria, details of a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or training set information.

To answer your request, I would need a different type of document, such as a clinical study report, a detailed performance test report, or a marketing clearance submission that includes these specific sections.

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