{"product_id":"fda-510k-k231505-gore-acuseal-vascular-graft","title":"FDA 510(k) K231505, GORE® ACUSEAL Vascular Graft, by W. L. Gore \u0026 Associates, Inc.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eGORE® ACUSEAL Vascular Graft\u003c\/strong\u003e (K231505), submitted by W. L. Gore \u0026amp; Associates, Inc..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K231505\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Prosthesis, Vascular Graft, Of 6mm And Greater Diameter\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e W. L. Gore \u0026amp; Associates, Inc.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 05\/24\/2023\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 06\/23\/2023\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 870.345\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e DSY\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubsequent Product Code:\u003c\/strong\u003e DYF\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Cardiovascular\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Cardiovascular\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 348 (215 unredacted, 38% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e✗ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 83% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 73% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 76% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 79% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 69% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 76% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 80% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 84% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 70% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 9% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 69% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51454814322852,"sku":"FDA510K231505","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k231505-gore-acuseal-vascular-graft","provider":"FOIA Document Source","version":"1.0","type":"link"}