Product code KRA

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
Catheter, Continuous Flush
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.1210
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
K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation2026-05-15
K250794InVera Infusion DeviceInvera Medical2026-03-12
K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited2025-07-30
K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLC2023-11-29
K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.2023-07-05
K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd.2023-06-20
K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences2023-05-02
K223139Wallaby 017 Micro CatheterWallaby Medical2023-04-25
K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration CanisterArgon Medical Devices, Inc.2023-04-10
K230636Maestro MicrocatheterMerit Medical System, Inc.2023-03-30
K222679Vericor Support CatheterVascupatent Medical (Shenzhen) Co., Ltd.2022-11-07
K213435MAGIC Flow-Dependent MicrocatheterBalt USA, LLC2022-07-19
K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB2022-06-10
K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL2022-04-12
K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.2022-04-11
K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.2022-01-07
K210838PROWLER SELECT PLUS; PROWLER EXMedos International SARL2021-08-25
K210339Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.2021-08-02
K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.2021-07-16
K210808Instylla Microcatheter 1.2Instylla, Inc.2021-04-15
K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular2021-02-16
K202366MAGIC Infusion CatheterBalt USA, LLC2021-01-29
K202318Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-09-14
K193082Fountain ValveTip Infusion CatheterMerit Medical Systems, Inc.2020-08-07
K201907ClariVein ICMerit Medical Systems, Inc.2020-08-06
K201792TRUSELECT MicrocatheterBoston Scientific Corporation2020-07-28
K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.2020-06-25
K200744Instylla MicrocatheterInstylla, Inc.2020-04-21
K191305Hereaeus Poseidon MicrocatheterHeraeus Medical Components, LLC2019-12-19
K193107TriSalus Infusion SystemTrisalus Life Sciences2019-12-03

Related GUDID Devices

Primary DIBrandCompanyPublished
10884450826178Fountain®Merit Medical Systems, Inc.2026-03-21
10884450470418Fountain®Merit Medical Systems, Inc.2026-03-19
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.2026-03-13
00860008103819Recana Debulking CatheterIntervene, Inc.2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.2026-03-02
10884450826352Fountain®Merit Medical Systems, Inc.2026-02-21
10884450826222Fountain®Merit Medical Systems, Inc.2026-02-18
10884450826543Fountain®Merit Medical Systems, Inc.2026-02-14
10884450826635Fountain®Merit Medical Systems, Inc.2026-02-14
G544ADM18147Agile AnglerAgile Devices, Inc.2026-01-30
G544ADM18130Agile AnglerAgile Devices, Inc.2026-01-30
10884450826185Fountain®Merit Medical Systems, Inc.2026-01-29
10884450826208Fountain®Merit Medical Systems, Inc.2026-01-16
00884450742921Merit Maestro®Merit Medical Systems, Inc.2026-01-03
10884450826512Fountain®Merit Medical Systems, Inc.2025-11-12
00857136004316TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.2025-09-29
00857136004323TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.2025-09-29
00884450742914Merit Maestro®Merit Medical Systems, Inc.2025-09-19
10884450826420Fountain®Merit Medical Systems, Inc.2025-08-06
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