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。

上市药品（NDC）器械分类 510(k) 许可

查询器械在 FDA 的管理类别（I/II/III 类）、产品代码与 21 CFR 法规号，是判断注册路径（豁免 / 510(k) / PMA）的第一步。

已将中文关键词转为英文「catheter」检索 FDA 数据库。

共找到 213 条与「catheter」匹配的结果

当前展示 50 条FDA 器械分类记录；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 ›

器械名称	管理类别	产品代码	法规号（21 CFR）	所属科室	定义 / 用途
Catheter, Septostomy	II 类	DXF	21 CFR 870.5175	Cardiovascular
Catheter, Nephrostomy	未分类	LJE	—	Unknown
Catheter, Nasopharyngeal	I 类	ENW	21 CFR 874.4175	Ear, Nose, Throat
Catheter, Steerable, Reprocessed	II 类	NKS	21 CFR 870.1280	Cardiovascular	Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Drug-Coated Peripheral Transluminal Angioplasty Catheter	III 类	PRC	—	Unknown	Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
Catheter, Retention, Barium Enema With Bag	II 类	FGD	21 CFR 876.5980	Gastroenterology, Urology
Fully Subcutaneous Implanted Hemodialysis Catheter	II 类	PKI	21 CFR 876.5540	Gastroenterology, Urology	Provides access to the blood for hemodialysis or other chronic uses.
Catheter, Percutaneous, Intraspinal, Short Term	II 类	MAJ	21 CFR 868.5120	Anesthesiology
Catheter, Thrombus Retriever	II 类	NRY	21 CFR 870.1250	Cardiovascular	The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Septostomy Catheter, Reprocessed	II 类	QLZ	21 CFR 870.5175	Cardiovascular	To create or enlarge an atrial septal defect in the heart.
Catheter, Malecot	II 类	FEW	21 CFR 876.5090	Gastroenterology, Urology
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor	II 类	PFJ	21 CFR 884.4260	Obstetrics/Gynecology	Mechanical dilation of the cervical canal for labor.
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	I 类	NNZ	21 CFR 876.5250	Gastroenterology, Urology	Urine collector and accessories; see product code EYZ.
Guide, Wire, Catheter, Neurovasculature	II 类	MOF	21 CFR 870.1330	Cardiovascular
Percutaneous Catheter, Ultrasound	II 类	PPN	21 CFR 870.1250	Cardiovascular	Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	III 类	OOB	—	Unknown	A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion. A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis.
Catheter, Retention Type	II 类	EZK	21 CFR 876.5980	Gastroenterology, Urology
Collector, Urine, (And Accessories) For Indwelling Catheter	II 类	KNX	21 CFR 876.5250	Gastroenterology, Urology
Catheter, Coude	II 类	EZC	21 CFR 876.5130	Gastroenterology, Urology
Catheter Access Cover, Tamper-Resistant	II 类	PZW	21 CFR 880.5970	General Hospital	A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter
Catheter, Irrigation	I 类	GBX	21 CFR 878.4200	General, Plastic Surgery
Cardiopulmonary Bypass Catheter Kit	II 类	OEU	21 CFR 870.4210	Cardiovascular	This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Catheter, Balloon, Transcervical	III 类	MKN	—	Unknown
Catheter Remote Control System	II 类	PJB	21 CFR 870.5700	Cardiovascular	A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures	II 类	SCZ	21 CFR 870.1254	Cardiovascular	The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures.
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	III 类	OAD	—	Unknown	For the treatment of atrial flutter.
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	II 类	PUM	21 CFR 870.1251	Cardiovascular	Embolic protection for transcatheter intracardiac procedures
Collector, Urine, Powered, Non Indwelling Catheter	I 类	NZU	21 CFR 876.5250	Gastroenterology, Urology	For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.
Port & Catheter, Implanted, Subcutaneous, Intravascular	II 类	LJT	21 CFR 880.5965	General Hospital
Catheter, Pressure Monitoring, Cardiac	II 类	OBI	21 CFR 870.1200	Cardiovascular	To measure pressure within the cardiovascular system.
Catheter, Percutaneous (Valvuloplasty)	III 类	MAD	—	Unknown
Intravenous Catheter Force-Activated Separation Device.	II 类	QOI	21 CFR 880.5220	General Hospital	An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.
Light, Catheter, Fiberoptic, Glass, Ureteral	II 类	FCS	21 CFR 876.4020	Gastroenterology, Urology
Replacement Gastrostomy Feeding Catheter Tray	II 类	PSK	21 CFR 876.5980	Gastroenterology, Urology	This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
System, Water Jet Catheter, Renal	II 类	FFE	21 CFR 876.4650	Gastroenterology, Urology
Lumbar Drainage Catheter Kit	II 类	PVO	21 CFR 882.5550	Neurology	This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Catheter, Femoral	II 类	LFK	21 CFR 876.5540	Gastroenterology, Urology
Non-Bronchoscopic Bronchoalveolar Lavage Catheter	I 类	OYI	21 CFR 868.6810	Anesthesiology	To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Adaptor, Ureteral Catheter	I 类	EYI	21 CFR 876.5130	Gastroenterology, Urology
Catheter, Straight	II 类	EZD	21 CFR 876.5130	Gastroenterology, Urology
Catheter, Peritoneal, Long-Term Indwelling	II 类	FJS	21 CFR 876.5630	Gastroenterology, Urology
Reprocessed Catheter Introducer	II 类	PNE	21 CFR 870.1340	Cardiovascular	Introduce various cardiovascular catheters into the heart and cardiovascular system
Biliary Catheter For Irrigation And Contrast Injection, Exempt	II 类	PTT	21 CFR 876.5010	Gastroenterology, Urology	This product code is the class II exempt counterpart of GCA, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Catheter, Percutaneous, Long Term, Intraspinal	III 类	LNY	—	Unknown
Catheter, Hemodialysis, Triple Lumen, Implanted	II 类	NIF	21 CFR 876.5540	Gastroenterology, Urology	Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.
Implanted Subcutaneous Securement Catheter	II 类	OKC	21 CFR 880.5970	General Hospital	Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.
System, Catheter Control, Steerable	II 类	DXX	21 CFR 870.1290	Cardiovascular
Hemodialysis Catheter Luer End Cap	II 类	PEH	21 CFR 876.5540	Gastroenterology, Urology	For use in hemodialysis catheters to reduce hub infection.
Catheter, Rectal For Continent Ileostomy	I 类	KPH	21 CFR 876.5030	Gastroenterology, Urology
Catheter, Ultrasound, Intravascular	II 类	OBJ	21 CFR 870.1200	Cardiovascular	For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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。

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