DQX

Wire, Guide, Catheter

产品代码
DQX
器械名称
Wire, Guide, Catheter
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 870.1330
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)
34 件
其中 Summary 已存档
32 份,可直接下载
FDA 历史累计 510(k)
766 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(34 件)

数据窗口为最近三年。最新一件:2026-07-14。

510(k) 号批准日期申请人器械名称摘要
K2536672026-07-14Sp Medical A/SAccoat Guide WirePDF
K2616402026-07-13Merit Medical Ireland , Ltd.Merit MAK Nitinol/Gold-Tungsten Guide WirePDF
K2541372026-05-22Merit Medical Ireland, Ltd.InQwire Amplatz Guide WirePDF
K2605442026-03-20FMD Co., Ltd.FMD Peripheral Guide Wire F-14 Flex 6; FMD Periphera…PDF
K2537462026-03-19Lake Region MedicalEnroute 0.014'' Transcarotid GuidewirePDF
K2532622026-03-06Nano4imaging GmbHEmeryGlide™ (EG18008901)PDF
K2538472026-01-31Merit Medical Ireland, Ltd.Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)PDF
K2513852026-01-21Merit Medical Ireland, Ltd.InQwire Super Stiff Guide Wire (IQSS32180J3); InQwir…PDF
K2526742026-01-09Solo Pace, Inc.Solo Pace Fusion System (SOLOFUSE1)PDF
K2515962025-11-09William Cook Europe ApsLunderquist Extra Stiff Wire GuidePDF
K2502032025-10-17Sureax Medical, LLCSureAx-Guide™PDF
K2500312025-10-03ABBOTT MEDICALAmplatzer GuidewirePDF
K2511812025-08-29Merit Medical Ireland, Ltd.Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5);…PDF
K2505522025-07-25ABBOTT MEDICALHi-Torque Command 14 ST Guide Wire and Hi-Torque Com…PDF
K2500752025-06-13Medtronic, Inc.Medtronic Stedi Extra Support GuidewirePDF
K2437332025-04-02Asahi Intecc Co., Ltd.SION blue PLUSPDF
K2419622025-03-27Asahi Intecc Co., Ltd.CrossloopPDF
K2425972025-03-05Asahi Intecc Co., Ltd.CROSSLEAD 0.018inchPDF
K2417022025-02-06Asahi Intecc Co., Ltd.CROSSLEAD 0.014inchFDA
K2415212024-12-10Merit Medical Systems, Inc.Prelude Small O.D. Introducer Guide WirePDF
K2428242024-12-06Lake Region MedicalPTFE GuidewireFDA
K2408182024-11-26Terumo CorporationR2P Radifocus Glidewire AdvantagePDF
K2409972024-11-06ABBOTT MEDICALHi-Torque Command 14 ST Guide Wire and Hi-Torque Com…PDF
K2417842024-09-18Teleflex MedicalArrow® Nitinol WirePDF
K2408592024-08-21Terumo CorporationGlidewire GT-RPDF
K2415102024-08-14Asahi Intecc Co., Ltd.CROSSLEAD TrackerPDF
K2403872024-06-21Asahi Intecc Co., Ltd.MINAMO blue; MINAMO violaPDF
K2404602024-06-13FMD Co., Ltd.FMD Peripheral Guide Wire F-18 Flex 400 (CSU41540025…PDF
K2408642024-05-24Opsens, Inc.PacePro WirePDF
K2326622024-05-14Biomerics NleBNLE Hydrophilic Jacketed Peripheral GuidewirePDF
K2304182023-10-28Merit Medical Systems, Inc.Mighty Wire Guide WirePDF
K2325702023-10-24Medtronic VascularSteerant™ Super Stiff GuidewirePDF
K2325782023-10-11Filmec Co. , Ltd.VASSALLO GT 018 G12; VASSALLO GT 018 G30PDF
K2325742023-10-11Filmec Co. , Ltd.VASSALLO GT Crossing14PDF

其中 32 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: DQX
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。