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Gelweave™ branched vascular grafts: "Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation".

"Gelweave™ branched vascular grafts, including Siena™ grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures".

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The provided document is a 510(k) premarket notification letter from the FDA regarding the "Gelweave™ Branched Vascular Grafts with Radiopaque Markers." This document officially clears the device for marketing based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be typically found in a clinical study report or a detailed technical submission.

Therefore, I cannot provide the requested information from the given text.

The document primarily states:

• The device name and its classification (Class II, Product Code DSY).
• The indications for use (repair or replacement of damaged/diseased vessels of the abdomen and thoracic aorta, and debranching/hybrid procedures).
• That the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
• General regulatory requirements for the manufacturer.

To answer your questions, one would need to review the actual 510(k) submission document (which is typically much more extensive than this clearance letter) or a separate clinical study report from the manufacturer.

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