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InterGard Knitted Ultra Thin Vascular Graft

• InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
  HemaCarotid Patch Ultra Thin
  The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.

InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches

This document is a 510(k) clearance letter from the FDA, which declares substantial equivalence for the InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical trial report or a performance study would.

Therefore, I cannot provide the requested information based on the provided text, as this document type typically does not include the details of performance studies or acceptance criteria tables. The FDA 510(k) clearance process relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive new performance studies in all cases.

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