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) | Device | Applicant | Decision date |
|---|---|---|---|
| K260771 | TruSelect 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 |
| K250794 | InVera Infusion Device | Invera Medical | 2026-03-12 |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 |
| K231821 | XO 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, LLC | 2023-11-29 |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | 2023-07-05 |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mm | Vvt Medical , Ltd. | 2023-06-20 |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023-05-02 |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023-04-25 |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister | Argon Medical Devices, Inc. | 2023-04-10 |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023-03-30 |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022-07-19 |
| K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022-06-10 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022-04-12 |
| K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022-04-11 |
| K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | 2022-01-07 |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | 2021-08-25 |
| K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2021-08-02 |
| K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | 2021-07-16 |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021-04-15 |
| K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021-02-16 |
| K202366 | MAGIC Infusion Catheter | Balt USA, LLC | 2021-01-29 |
| K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-14 |
| K193082 | Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. | 2020-08-07 |
| K201907 | ClariVein IC | Merit Medical Systems, Inc. | 2020-08-06 |
| K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | 2020-07-28 |
| K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020-06-25 |
| K200744 | Instylla Microcatheter | Instylla, Inc. | 2020-04-21 |
| K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | 2019-12-19 |
| K193107 | TriSalus Infusion System | Trisalus Life Sciences | 2019-12-03 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884450826178 | Fountain® | Merit Medical Systems, Inc. | 2026-03-21 |
| 10884450470418 | Fountain® | Merit Medical Systems, Inc. | 2026-03-19 |
| 00850044140015 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2026-03-13 |
| 00860008103819 | Recana Debulking Catheter | Intervene, Inc. | 2026-03-02 |
| 00860008103826 | Recana Collection Basket, 18mm | Intervene, Inc. | 2026-03-02 |
| 00860008103833 | Recana Collection Basket, 30mm | Intervene, Inc. | 2026-03-02 |
| 00860008103840 | Recana Introducer Sheath, 13Fr x 30cm | Intervene, Inc. | 2026-03-02 |
| 00860008103857 | Recana Introducer Sheath, 13Fr x 90cm | Intervene, Inc. | 2026-03-02 |
| 00860008103864 | Recana Introducer Sheath, 16Fr x 30cm | Intervene, Inc. | 2026-03-02 |
| 00860008103871 | Recana Introducer Sheath, 16Fr x 90cm | Intervene, Inc. | 2026-03-02 |
| 10884450826352 | Fountain® | Merit Medical Systems, Inc. | 2026-02-21 |
| 10884450826222 | Fountain® | Merit Medical Systems, Inc. | 2026-02-18 |
| 10884450826543 | Fountain® | Merit Medical Systems, Inc. | 2026-02-14 |
| 10884450826635 | Fountain® | Merit Medical Systems, Inc. | 2026-02-14 |
| G544ADM18147 | Agile Angler | Agile Devices, Inc. | 2026-01-30 |
| G544ADM18130 | Agile Angler | Agile Devices, Inc. | 2026-01-30 |
| 10884450826185 | Fountain® | Merit Medical Systems, Inc. | 2026-01-29 |
| 10884450826208 | Fountain® | Merit Medical Systems, Inc. | 2026-01-16 |
| 00884450742921 | Merit Maestro® | Merit Medical Systems, Inc. | 2026-01-03 |
| 10884450826512 | Fountain® | Merit Medical Systems, Inc. | 2025-11-12 |
| 00857136004316 | TriNav XP Infusion System | SUREFIRE MEDICAL, INC. | 2025-09-29 |
| 00857136004323 | TriNav XP Infusion System | SUREFIRE MEDICAL, INC. | 2025-09-29 |
| 00884450742914 | Merit Maestro® | Merit Medical Systems, Inc. | 2025-09-19 |
| 10884450826420 | Fountain® | Merit Medical Systems, Inc. | 2025-08-06 |
| 08714729786177 | Renegade™ HI-FLO™ FATHOM™ Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729786184 | Renegade™ HI-FLO™ FATHOM™ Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729786191 | Renegade™ HI-FLO™ FATHOM™ Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729786207 | Renegade™ HI-FLO™ FATHOM™ Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729786214 | Renegade™ HI-FLO™ FATHOM™ Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729786221 | Renegade™ HI-FLO™ FATHOM™ Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |