{"product_id":"fda-510k-k242076","title":"FDA 510(k) K242076, VersaCross™ RF Wire, by Baylis Medical Company","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eCatheter, Septostomy\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK242076\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e VersaCross™ RF Wire\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Baylis Medical Company\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e870.5175\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eDXF\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e07\/16\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 11\/01\/2024\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 448\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 196\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 252\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313334878372,"sku":"FDA510K242076","price":788.33,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k242076","provider":"FOIA Document Source","version":"1.0","type":"link"}