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DYB

Introducer, Catheter

产品代码
DYB
器械名称
Introducer, Catheter
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 870.1340
FDA 专业组
Cardiovascular
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
706 件

该代码近三年的 510(k)（57 件）

数据窗口为最近三年。最新一件：2026-07-29。

510(k) 号批准日期申请人器械名称
K2535262026-07-29Medline Industries, LPNAMIC Dilator and Sheath 摘要
K2615292026-07-06Hartman Medical Group, LLCMicropuncture Kit / Micropuncture Access Kit / Micro 摘要
K2612422026-06-25PendracareSimplGuide 摘要
K2619502026-06-22Health Line International CorporationHealth Line Tearaway Introducer 摘要
K2614922026-06-05CenterPoint Systems, LLCFieldFlex Steerable Sheath 摘要
K2606062026-04-29Echo Medical, LLCEcho Large Bore Introducer Sheath 摘要
K2542482026-04-23Cardiocycle Medical(Suzhou) Co., Ltd.Introducer Sheath Set 摘要
K2542792026-04-17Edwards LifesciencesEdwards eSheath+ introducer set 摘要
K2600912026-04-13Inquis MedicalAventus Introducer Sheath 摘要
K2608392026-04-10Protaryx Medical, Inc.Protaryx Transseptal Puncture Device (PTX2-001) 摘要
K2609422026-04-07CenterPoint Systems, LLCAuST Steerable Sheath 摘要
K2604592026-04-06Zoll Respicardia, Inc.VANES Delivery System (VDS) 摘要
K2606262026-03-26Vizaramed, Inc.Multiflex Steerable Sheath 17.5F 摘要
K2601632026-02-19CenterPoint Systems, LLCAuST CSP Introducer 摘要
K2542362026-02-09VascuTech Medical, LLCPeel-Away Introducer Sheath 摘要
K2536522026-01-22Cultiv8 1, LLCGenie MAX Large Bore Introducer Sheath 摘要
K2525082025-12-17Inari Medical, Inc.Intri26 Introducer Sheath 摘要
K2537412025-12-15Argon Medical Devices, Inc.V•Stick™ Vascular Access Set 摘要
K2523092025-10-23Vivasure Medical LimitedPerQseal Introducers 摘要
K2518382025-10-21Cardiocycle Medical(Suzhou) Co., Ltd.Introducer Sheath Set 摘要
K2527662025-10-08Abiomed, Inc.14Fr Low Profile Introducer Kit 摘要
K2524412025-09-29South53, LLCPrimero Safe Access System 摘要
K2522272025-09-24Surmodics,Inc.Pounce(TM) Sheath 摘要
K2520272025-09-12Jupiter EndovascularVertex(TM) Catheter 摘要
K2523642025-08-29Edwards LifesciencesEdwards eSheath Optima introducer set 摘要
K2510512025-04-30CenterPoint Systems, LLCAuST Steerable Sheath 摘要
K2509092025-04-25Merit Medical Systems, Inc.Prelude Wave Hydrophilic Sheath Introducer 摘要
K2439542025-04-24Circa Scientific, Inc.PeriCross™ Epicardial Access Kit 摘要
K2440462025-03-27Edwards LifesciencesEdwards eSheath Optima introducer set 摘要
K2504682025-03-20Boston ScientificiSLEEVE Introducer Set 摘要
K2439282025-03-20Cardiovia , Ltd.ViaOne Epicardial Access System 摘要
K2504392025-03-16Contract Medical International, GmbHCatapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); C 摘要
K2434932024-12-13ABBOTT MEDICALAgilis NxT Steerable Introducer Dual-Reach 摘要
K2425202024-11-20Penumbra, Inc.Element Vascular Access System 摘要
K2427562024-11-08Pulnovo Medical (Wuxi) Co., Ltd.Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlex 摘要
K2430612024-11-04Sonostik, LLCSonoStik Guide Wire Introducer 摘要
K2421062024-10-04CenterPoint Systems, LLCAuST Steerable Sheath 摘要
K2412302024-09-17Togo Medikit Co., Ltd.Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 摘要
K2406002024-09-06East End Medical I, LLCSafeCross Vascular Introducer System (4001) 摘要
K2421692024-08-23BiocardiaMorph DNA Steerable Introducer Sheath 摘要
K2422482024-08-22Beijing Demax Medical Technology Co.,LIntroducer Sheath Kits
K2409572024-08-14Contract Medical International, GmbHCatapult Guide Sheath 摘要
K2417082024-08-06Abiomed, Inc.Abiomed 14Fr Low Profile Introducer Kit 摘要
K2411452024-08-01Argon Medical Devices, Inc.TLAB® Transvenous Liver Biopsy System (TF-18C) 摘要
K2413702024-06-13ABBOTT MEDICALAgilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-M 摘要
K2408292024-05-01CenterPoint Systems, LLCAuST Steerable Sheath 摘要
K2405892024-03-25Cook MedicalMicropuncture Introducer Sets; Micropuncture Pedal A 摘要
K2337082024-02-16Synaptic Medical CorporationNaviGo 12F Steerable Intracardiac Catheter Introduce 摘要
K2339592024-02-13AtriCure, Inc.EPi-Ease Epicardial Access Device (EAS) 摘要
K2400042024-01-31Circa Scientific, Inc.CardioCurve Steerable Sheath Small Curl, 40cm (CC-10 摘要
K2312272023-12-20Baylis Medical Company, Inc.SureFlex HD Steerable Sheath, VersaCross HD Steerabl 摘要
K2336912023-12-17Acutus Medical, Inc.FlexCath Cross Transseptal Solution 摘要
K2336462023-12-12Inari Medical, Inc.Intri24 Introducer Sheath (52-101) 摘要
K2334322023-12-08Argon Medical Devices, Inc.10F Sheath and Dilator Set 摘要
K2335032023-11-30Boston Scientific Corporation14F iSLEEVE Introducer Set 摘要
K2322602023-09-27Inneuroco, Inc.Thinline Sheath Introducer 摘要
K2311082023-09-27Inari Medical, Inc.Talon Transseptal Sheath 摘要
FDA 官方分类页： DYB
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。