QJP

Catheter, Percutaneous, Neurovasculature

产品代码
QJP
器械名称
Catheter, Percutaneous, Neurovasculature
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 870.1250
FDA 专业组
Cardiovascular
上市路径
需提交 510(k) 上市前通告
该代码近三年的 510(k)
58 件
其中 Summary 已存档
53 份,可直接下载
FDA 历史累计 510(k)
98 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(58 件)

数据窗口为最近三年。最新一件:2026-08-28。

510(k) 号批准日期申请人器械名称摘要
K2611762026-08-28Imperative Care, Inc.Zoom 4S CatheterPDF
K2540712026-08-18Wallaby Medicalp17 XR MicrocatheterPDF
K2601992026-07-13Balt USA, LLCSLIM MicrocatheterPDF
K2539012026-07-09Perfuze, Ltd.Millipede88 Access CatheterPDF
K2618892026-07-01Stryker NeurovascularTrevo Trak 21 MicrocatheterPDF
K2618082026-06-30Microvention Inc. d/b/a Terumo NeuroISAAC Neurovascular Navigation CatheterPDF
K2615492026-06-09MicroVention, Inc., d/b/a Terumo NeuroBOBBY Balloon Guide CatheterPDF
K2533592026-05-22Suzhou Zenith Vascular SciTech LimitedZenith Distal Access Long SheathPDF
K2541782026-05-11Asahi Intecc Co., Ltd.SAYA 86 Radial Access Guide CatheterPDF
K2540462026-04-21Sonorous NV, Inc.BosCATH Support CatheterPDF
K2542232026-04-16Balt USA, LLCNext Generation 088 CatheterPDF
K2609382026-04-15Crossroads Neurovascular, Inc.PATH BGCPDF
K2539752026-04-09Maduro Medical, Inc.Radical 6F Access CatheterPDF
K2530322026-02-11Stryker NeurovascularAXS Lift Intracranial Base CatheterPDF
K2522972026-01-16Toro Neurovascular, Inc.Toro 88 Superbore CatheterPDF
K2510972026-01-06Vesalio, Inc.V-DAC CatheterPDF
K2516682026-01-05Kaneka Americas Holding, Inc.SurfRider 13 MicrocatheterPDF
K2522132025-12-03Bend IT Technologies, Ltd.Bendit17 MicrocatheterPDF
K2513722025-10-24Unity Medical, Inc.VersaD Delivery CatheterPDF
K2525692025-10-22Balt USA, LLCCarrier XL Delivery CatheterFDA
K2509602025-09-08Rev Neuro, LLCDUO MicrocatheterPDF
K2515602025-06-20Asahi Intecc Co., Ltd.FUBUKI XF-R Neurovascular Long SheathPDF
K2512402025-06-20Asahi Intecc Co., Ltd.Branchor X Balloon Guide CatheterPDF
K2510442025-05-23Piraeus Medical93 NeuFlex CatheterPDF
K2423922025-05-09Crossroads Neurovascular, Inc.PATH BGCFDA
K2422892025-03-21Stryker NeurovascularExcelsior XT-27 Microcatheter, Excelsior XT-27 Flex PDF
K2435932025-02-18Stryker NeurovascularAXS Lift Intracranial Base CatheterPDF
K2420512025-01-17Unity Medical, Inc.VersaD Delivery CatheterPDF
K2432972025-01-14Alembic, LLCAPRO 70 Swift CatheterPDF
K2435772025-01-14Maduro Medical, Inc.Radical the Dude 8F Guide CatheterPDF
K2413882025-01-02Micro Therapeutics, Inc. d/b/a ev3 NeuRist 079 Radial Access Guide Catheter; Rist 071 RadiPDF
K2423762024-12-30Balt USA, LLCNext Generation Access PlatformFDA
K2416372024-12-19Stryker NeurovascularEcho Intracranial Base CatheterPDF
K2417682024-12-19Stryker NeurovascularBroadway 8 CatheterPDF
K2420332024-12-11Penumbra, Inc.Access25™ Delivery MicrocatheterPDF
K2409712024-12-06Piraeus Medical87 NeuGlide CatheterPDF
K2423012024-12-04Scientia Vascular, Inc.Socrates 38 CatheterPDF
K2407462024-11-20Q'Apel Medical, Inc.Neurovascular Access System FamilyPDF
K2407112024-10-17Perfuze, Ltd.Zipline Access CatheterPDF
K2412442024-10-16Cerenovus, Inc.CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 IntPDF
K2405292024-10-02Route 92 Medical, Inc.8F Modified Sheath SystemPDF
K2340742024-07-02Balt USA, LLCNext Generation Access CatheterPDF
K2409482024-06-06Imperative Care, Inc.TracStar LDP Large Distal Platform; Zoom 88 Large DiPDF
K2325422024-05-16MicroVention, Inc.Wedge XL Delivery CatheterPDF
K2339822024-05-09Cerenovus, Inc.CEREGLIDE 92 Catheter SystemPDF
K2339242024-04-18Neuravi LimitedEMBOGUARD Balloon Guide CatheterPDF
K2332012024-03-27Penumbra, Inc.MIDWAY Delivery Catheter (MIDWAY 43 Delivery CathetePDF
K2310562024-03-08Wallaby MedicalEsperance Distal Access CatheterFDA
K2312182024-01-19Accumedical Beijing , Ltd.Distal Access CatheterPDF
K2332052023-12-22Shanghai Heartcare Medical Technology Distal Access CatheterPDF
K2336482023-12-14Perfuze, Ltd.Millipede 088 Access CatheterPDF
K2311792023-12-01Anoxia Medical, Inc.Slinky CatheterPDF
K2313932023-11-30Maduro Medical, Inc.Radical the Dude 7F Guide CatheterPDF
K2307262023-11-29Cerenovus, Inc.CEREGLIDE 92 Intermediate CatheterPDF
K2318022023-09-19Perfuze, Ltd.Millipede 088 Access CatheterPDF
K2229482023-09-19Mivi Neuroscience, Inc.Q Distal Access CatheterFDA
K2307752023-09-14MicroVention, Inc.SOFIA EX Intracranial Support CatheterPDF
K2306092023-09-13Balt USA, LLCNG Delivery CatheterPDF

其中 53 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: QJP
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。