Product code DRE

Product
Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical De
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Current FDA Classification

Device name
Dilator, Vessel, For Percutaneous Catheterization
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.1310
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible

Related Records

Related 510(k) Records

510(k)DeviceApplicantDecision date
K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.2025-12-19
K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.2025-05-29
K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.2025-01-15
K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.2024-07-12
K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.2023-12-14
K232609Micro Ace™ Advanced Micro Access SystemMerit Medical Systems, Inc.2023-09-27
K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)Spectranetics, Inc.2022-12-15
K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc.2022-08-24
K211679Xtractor deviceXcardia Innovation , Ltd.2022-02-17
K210734Endovascular Dilator and SetsCook Incorporated2021-04-06
K201288ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc.2020-06-12
K192283MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE DilatorMedron, LLC2020-05-06
K200379Super SheathTogo Medikit Co., Ltd.2020-03-19
K192195Sterile DilatorGalt Medical Corp.2019-09-26
K190175S-MAK XLMerit Medical Systems, Inc.2019-04-10
K182064ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc.2019-03-21
K183036Dilator SetsCook Incorporated2018-12-20
K182914MC3 Vascular Access Kit 21030Mc3 Incorporated2018-10-29
K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp.2017-10-16
K162389Medcomp Vessel DilatorMedcomp ( Medical Components)2017-06-01
K170616van Andel Dilatation CatheterCook Incorporated2017-04-28
K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc.2017-01-06
K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc.2016-08-11
K150932Sheath IntroducerBioteque Corp.2016-07-22
K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc.2016-07-08
K151877MicroTract Access SystemArstasis, Inc.2015-08-07
K151076MicroTaper Needle Introducer SetSummit Access, LLC2015-05-22
K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc.2015-03-04
K141070SUPER SHEATHTogo Medikit Co., Ltd.2015-01-15
K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization SheathCook Vascular, Inc.2014-11-12

Related GUDID Devices

Primary DIBrandCompanyPublished
10884450845223Merit Medical®Merit Medical Systems, Inc.2026-03-24
10884450441784SteadySheath®Merit Medical Systems, Inc.2026-03-21
10884450441616Evolution® RLMerit Medical Systems, Inc.2026-03-11
10884450441746Evolution® RLMerit Medical Systems, Inc.2026-03-11
10884450441753Evolution® RLMerit Medical Systems, Inc.2026-03-11
10884450441623Evolution® RLMerit Medical Systems, Inc.2026-03-10
10884450441777SteadySheath®Merit Medical Systems, Inc.2026-03-06
10884450441791SteadySheath®Merit Medical Systems, Inc.2026-03-06
10884450441807SteadySheath® ShortieMerit Medical Systems, Inc.2026-03-06
10884450441760Evolution® Shortie RLMerit Medical Systems, Inc.2026-03-05
20884450707795Prelude®Merit Medical Systems, Inc.2026-02-14
08033178019590PROTEK DILATESORIN GROUP ITALIA SRL2026-01-16
20884450708945Prelude®Merit Medical Systems, Inc.2026-01-16
20884450706798Prelude®Merit Medical Systems, Inc.2026-01-16
08033178019583PROTEK DILATESORIN GROUP ITALIA SRL2026-01-16
08033178019576PROTEK DILATESORIN GROUP ITALIA SRL2026-01-16
08033178019552PROTEK DILATESORIN GROUP ITALIA SRL2026-01-16
08033178019545PROTEK DILATESORIN GROUP ITALIA SRL2026-01-16
10884450847333Merit MAK™Merit Medical Systems, Inc.2025-12-05
10884521811188RitusMozarc Medical US LLC2025-11-27
10884450587185Merit PAK™Merit Medical Systems, Inc.2025-09-05
20884450707177Prelude ACT™Merit Medical Systems, Inc.2025-09-04
20884450708976Prelude®Merit Medical Systems, Inc.2025-08-26
10884450846787Merit MAK Gold™Merit Medical Systems, Inc.2025-08-15
20884450614628Prelude®Merit Medical Systems, Inc.2025-08-14
00763000925116FlexCath Cross™ Transseptal SolutionMEDTRONIC, INC.2025-08-10
00763000925130FlexCath Cross™ Transseptal SolutionMEDTRONIC, INC.2025-08-10
10884450847265Merit MAK Gold™Merit Medical Systems, Inc.2025-08-05
20884450076730Prelude® PROMerit Medical Systems, Inc.2025-07-24
10884450847340Merit S-MAK™Merit Medical Systems, Inc.2025-07-16