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) | Device | Applicant | Decision date |
|---|---|---|---|
| K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025-12-19 |
| K251325 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2025-05-29 |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | 2025-01-15 |
| K241720 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2024-07-12 |
| K233647 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2023-12-14 |
| K232609 | Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. | 2023-09-27 |
| K223472 | TightRail 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 |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022-08-24 |
| K211679 | Xtractor device | Xcardia Innovation , Ltd. | 2022-02-17 |
| K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021-04-06 |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020-06-12 |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | 2020-05-06 |
| K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020-03-19 |
| K192195 | Sterile Dilator | Galt Medical Corp. | 2019-09-26 |
| K190175 | S-MAK XL | Merit Medical Systems, Inc. | 2019-04-10 |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019-03-21 |
| K183036 | Dilator Sets | Cook Incorporated | 2018-12-20 |
| K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | 2018-10-29 |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | 2017-10-16 |
| K162389 | Medcomp Vessel Dilator | Medcomp ( Medical Components) | 2017-06-01 |
| K170616 | van Andel Dilatation Catheter | Cook Incorporated | 2017-04-28 |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017-01-06 |
| K161336 | VSI StraitSet micro-introducer kit | Vascular Solutions, Inc. | 2016-08-11 |
| K150932 | Sheath Introducer | Bioteque Corp. | 2016-07-22 |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016-07-08 |
| K151877 | MicroTract Access System | Arstasis, Inc. | 2015-08-07 |
| K151076 | MicroTaper Needle Introducer Set | Summit Access, LLC | 2015-05-22 |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Spectranetics, Inc. | 2015-03-04 |
| K141070 | SUPER SHEATH | Togo Medikit Co., Ltd. | 2015-01-15 |
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | Cook Vascular, Inc. | 2014-11-12 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884450845223 | Merit Medical® | Merit Medical Systems, Inc. | 2026-03-24 |
| 10884450441784 | SteadySheath® | Merit Medical Systems, Inc. | 2026-03-21 |
| 10884450441616 | Evolution® RL | Merit Medical Systems, Inc. | 2026-03-11 |
| 10884450441746 | Evolution® RL | Merit Medical Systems, Inc. | 2026-03-11 |
| 10884450441753 | Evolution® RL | Merit Medical Systems, Inc. | 2026-03-11 |
| 10884450441623 | Evolution® RL | Merit Medical Systems, Inc. | 2026-03-10 |
| 10884450441777 | SteadySheath® | Merit Medical Systems, Inc. | 2026-03-06 |
| 10884450441791 | SteadySheath® | Merit Medical Systems, Inc. | 2026-03-06 |
| 10884450441807 | SteadySheath® Shortie | Merit Medical Systems, Inc. | 2026-03-06 |
| 10884450441760 | Evolution® Shortie RL | Merit Medical Systems, Inc. | 2026-03-05 |
| 20884450707795 | Prelude® | Merit Medical Systems, Inc. | 2026-02-14 |
| 08033178019590 | PROTEK DILATE | SORIN GROUP ITALIA SRL | 2026-01-16 |
| 20884450708945 | Prelude® | Merit Medical Systems, Inc. | 2026-01-16 |
| 20884450706798 | Prelude® | Merit Medical Systems, Inc. | 2026-01-16 |
| 08033178019583 | PROTEK DILATE | SORIN GROUP ITALIA SRL | 2026-01-16 |
| 08033178019576 | PROTEK DILATE | SORIN GROUP ITALIA SRL | 2026-01-16 |
| 08033178019552 | PROTEK DILATE | SORIN GROUP ITALIA SRL | 2026-01-16 |
| 08033178019545 | PROTEK DILATE | SORIN GROUP ITALIA SRL | 2026-01-16 |
| 10884450847333 | Merit MAK™ | Merit Medical Systems, Inc. | 2025-12-05 |
| 10884521811188 | Ritus | Mozarc Medical US LLC | 2025-11-27 |
| 10884450587185 | Merit PAK™ | Merit Medical Systems, Inc. | 2025-09-05 |
| 20884450707177 | Prelude ACT™ | Merit Medical Systems, Inc. | 2025-09-04 |
| 20884450708976 | Prelude® | Merit Medical Systems, Inc. | 2025-08-26 |
| 10884450846787 | Merit MAK Gold™ | Merit Medical Systems, Inc. | 2025-08-15 |
| 20884450614628 | Prelude® | Merit Medical Systems, Inc. | 2025-08-14 |
| 00763000925116 | FlexCath Cross™ Transseptal Solution | MEDTRONIC, INC. | 2025-08-10 |
| 00763000925130 | FlexCath Cross™ Transseptal Solution | MEDTRONIC, INC. | 2025-08-10 |
| 10884450847265 | Merit MAK Gold™ | Merit Medical Systems, Inc. | 2025-08-05 |
| 20884450076730 | Prelude® PRO | Merit Medical Systems, Inc. | 2025-07-24 |
| 10884450847340 | Merit S-MAK™ | Merit Medical Systems, Inc. | 2025-07-16 |