FDA 药品与器械查询
实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。
数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。
支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。
检索已获 FDA 上市前通告许可的器械清单，可查看同类产品的申请人、K 号与许可日期，用于竞品与等效器械调研。
已将中文关键词转为英文「catheter」检索 FDA 数据库。
共找到 4693 条与「catheter」匹配的结果
当前展示 50 条FDA 510(k) 许可记录； 海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›
| K 号 | 器械名称 | 申请人 | 许可日期 | 结论 | 产品代码 | 审查科室 |
|---|---|---|---|---|---|---|
| K193440 | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | 2020-01-09 | Substantially Equivalent | MJN | Cardiovascular |
| K840339 | UMBILICAL VESSEL CATHETER | Catheter Technology Corp. | 1984-07-25 | Substantially Equivalent | FOS | General Hospital |
| K092657 | EPIFUSE CATHETER CONNECTOR, MODEL: 4909E | Smiths Medical Asd, Inc. | 2009-11-04 | Substantially Equivalent | CAZ | Anesthesiology |
| K234115 | APRO 55 Catheter | Alembic, LLC | 2024-03-15 | Substantially Equivalent | DQY | Cardiovascular |
| K112327 | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-09 | Substantially Equivalent | DSP | Cardiovascular |
| K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | Amsino International, Inc. | 2010-09-13 | Substantially Equivalent | EZL | Gastroenterology, Urology |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | Maquet Critical Care AB | 2026-08-26 | Substantially Equivalent | PIF | Gastroenterology, Urology |
| K822034 | BALLOON WEDGE PRESSURE CATHETER | Ziehm International, Inc. | 1982-08-24 | Substantially Equivalent | DYG | Cardiovascular |
| K012749 | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 | Biocardia, Inc. | 2002-01-24 | Substantially Equivalent | DQO | Cardiovascular |
| K900756 | ITC INTRODUCER CATHETER | Interventional Therapeutics Corp. | 1990-08-08 | Substantially Equivalent | DYB | Cardiovascular |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | Gentuity, LLC | 2024-08-16 | Substantially Equivalent | NQQ | Radiology |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | Centerline Biomedical, Inc. | 2019-06-24 | Substantially Equivalent | DQK | Cardiovascular |
| K024165 | DUAL-LUMEN CATHETER | Bistech, Inc. | 2003-01-10 | Substantially Equivalent | EOQ | Ear, Nose, Throat |
| K013517 | 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 | Medtronic Vascular | 2002-04-25 | Substantially Equivalent | DQY | Cardiovascular |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. | 2024-06-27 | Substantially Equivalent | MCW | Cardiovascular |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Hansen Medical, Inc. | 2013-09-27 | Substantially Equivalent | DXX | Cardiovascular |
| K832916 | INIVOX ELECTRODE/CATHETER SYS | Critikon Company, LLC | 1983-11-14 | Substantially Equivalent | LLE | Unknown |
| K102405 | INFUSION SET FOR POWERPICC SOLO 2 CATHETER | C.R. Bard, Inc. | 2011-07-21 | Substantially Equivalent | FPA | General Hospital |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | The Kendal Co. | 1999-09-28 | Substantially Equivalent | EZL | Gastroenterology, Urology |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-08 | Unknown | GBM | Gastroenterology, Urology |
| K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | Abbott Vascular-Cardiac Therapies | 2011-01-10 | Substantially Equivalent | LOX | Cardiovascular |
| K945556 | ANTERIOR/POSTERIOR EPISTAXIS CATHETER | Ultracell Medical Technologies, Inc. | 1995-01-18 | Substantially Equivalent | EMX | Ear, Nose, Throat |
| K981191 | ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 | Intratherapeutics, Inc. | 1999-04-07 | Substantially Equivalent | DQY | Cardiovascular |
| K823565 | MULTI-LUMEN INTRAVENOUS CATHETER | Mcpherson Enterprises, Inc. | 1982-12-16 | Substantially Equivalent | FOZ | General Hospital |
| K930232 | CVIS INSIGHT IMAGING GUIDE CATHETER | Cardiovascular Imaging Systems, Inc. | 1993-07-21 | Substantially Equivalent | DQO | Cardiovascular |
| K101479 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2010-08-11 | Substantially Equivalent | DQY | Cardiovascular |
| K993245 | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM | Alba Critical Care, Ltd. | 1999-10-28 | Substantially Equivalent | DYG | Cardiovascular |
| K974015 | ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL | Davis & Geck, Inc. | 1998-05-18 | Substantially Equivalent | FOZ | General Hospital |
| K162900 | PowerMidline Catheter | C.R. Bard, Inc. | 2016-12-14 | Substantially Equivalent | PND | General Hospital |
| K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | Hollister, Inc. | 2009-08-20 | Substantially Equivalent | GBM | Gastroenterology, Urology |
| K984150 | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | Ep Medsystems | 1999-02-22 | Substantially Equivalent | DRF | Cardiovascular |
| K915625 | INTRODUCER CATHETER | Interventional Therapeutics Corp. | 1992-06-03 | Substantially Equivalent | DYB | Cardiovascular |
| K801415 | LATEX FOLEY CATHETER (HYDROMER COATED) | G.D. Searle and Co. | 1980-08-20 | Substantially Equivalent | KOD | Gastroenterology, Urology |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | Transonic Systems, Inc. | 2002-03-19 | Substantially Equivalent | DYG | Cardiovascular |
| K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO | Micrus Endovascular Corporation | 2011-01-26 | Substantially Equivalent | MJN | Cardiovascular |
| K243180 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2024-12-04 | Substantially Equivalent | DQY | Cardiovascular |
| K053277 | CPS DIRECT SL OUTER CATHETER | St Jude Medical | 2006-02-24 | Substantially Equivalent | DQY | Cardiovascular |
| K813209 | TRACHEOBRONCHIAL SUCTION CATHETER | Hydromer, Inc. | 1981-12-09 | Substantially Equivalent | BSY | Anesthesiology |
| K213466 | Houdini Cross Support Catheter | Cruzar Medsystems, Inc. | 2022-10-20 | Substantially Equivalent | DQY | Cardiovascular |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2024-11-01 | Substantially Equivalent | DRF | Cardiovascular |
| K150452 | ComboCath OTW PTA Dilatation Catheter | Summa Therapeutics, LLC | 2015-08-13 | Substantially Equivalent | LIT | Cardiovascular |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | 2023-01-20 | Substantially Equivalent | LIT | Cardiovascular |
| K890024 | SARNS VENT CATHETER | 3M Company | 1989-03-02 | Substantially Equivalent | DWF | Cardiovascular |
| K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA | Loma Vista Medical | 2012-10-11 | Substantially Equivalent | OZT | Cardiovascular |
| K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) | Marvao Medical Devices, Ltd. | 2018-02-08 | Unknown | MSD | Gastroenterology, Urology |
| K083711 | MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 | Barrx Medical, Incorporated | 2009-02-02 | Substantially Equivalent | GEI | General, Plastic Surgery |
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH | Hansen Medical, Inc. | 2007-05-02 | Unknown | DXX | Cardiovascular |
| K100251 | G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 | Usgi Medical | 2010-02-17 | Substantially Equivalent | GAT | General, Plastic Surgery |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2026-02-11 | Substantially Equivalent | QJP | Cardiovascular |
| K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2021-12-15 | Substantially Equivalent | PNO | Cardiovascular |
数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。