{"product_id":"fda-510k-k213398","title":"FDA 510(k) K213398, EMBOLD Fibered Detachable Coil System, by Boston Scientific Corporation","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eDevice, Vascular, For Promoting Embolization\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK213398\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e EMBOLD Fibered Detachable Coil System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Boston Scientific Corporation\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e870.3300\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eKRD\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e10\/18\/2021\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 04\/12\/2022\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eCardiovascular\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eCardiovascular\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 3,645\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 3,138\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 507\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221501092,"sku":"FDA510K213398","price":1307.31,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k213398","provider":"FOIA Document Source","version":"1.0","type":"link"}