{"product_id":"fda-510k-k222808","title":"FDA 510(k) K222808, Penumbra System (Reperfusion Catheter RED 43), by Penumbra, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eCatheter, Thrombus Retriever\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK222808\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Penumbra System (Reperfusion Catheter RED 43)\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Penumbra, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e870.125\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eNRY\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2022-09-16\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2022-12-20\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\u003eNeurology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,917\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,787\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 130\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51315539312804,"sku":"FDA510K222808","price":477.3,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k222808","provider":"FOIA Document Source","version":"1.0","type":"link"}