{"product_id":"fda-510k-k233407-atriclip-laa-exclusion-system-family-gillinov-cosgrove-pro-v-and-flex-v","title":"FDA 510(k) K233407, AtriClip LAA Exclusion System Family (Gillinov-Cosgrove, PRO-V and Flex-V), by AtriCure, Inc.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eAtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)\u003c\/strong\u003e (K233407), submitted by AtriCure, Inc..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K233407\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e AtriCure, Inc.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 11\/02\/2023\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e PZX PZX\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Cardiovascular\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal PDF Pages:\u003c\/strong\u003e 519\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFully Redacted Pages:\u003c\/strong\u003e 336\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUsable Pages:\u003c\/strong\u003e 183\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eSections Included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAdministrative \/ Introductory Materials:\u003c\/strong\u003e pages 1-362; 79.0% redacted (Heavy Redaction)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIndications for Use:\u003c\/strong\u003e pages 363-391; 17.2% redacted (Moderate Redaction)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePerformance Testing:\u003c\/strong\u003e pages 392-404; 15.4% redacted (Moderate Redaction)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIndications for Use:\u003c\/strong\u003e pages 405-408; 0.0% redacted (Unredacted)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePerformance Testing:\u003c\/strong\u003e pages 409; 0.0% redacted (Unredacted)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIndications for Use:\u003c\/strong\u003e pages 410-513; 39.4% redacted (Heavy Redaction)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePerformance Testing:\u003c\/strong\u003e pages 514-519; 33.3% redacted (Moderate Redaction)\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429458968740,"sku":"FDA510K233407","price":89.0,"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-k233407-atriclip-laa-exclusion-system-family-gillinov-cosgrove-pro-v-and-flex-v","provider":"FOIA Document Source","version":"1.0","type":"link"}