DQX
- 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)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253667 | 2026-07-14 | Sp Medical A/S | Accoat Guide Wire | |
| K261640 | 2026-07-13 | Merit Medical Ireland , Ltd. | Merit MAK Nitinol/Gold-Tungsten Guide Wire | |
| K254137 | 2026-05-22 | Merit Medical Ireland, Ltd. | InQwire Amplatz Guide Wire | |
| K260544 | 2026-03-20 | FMD Co., Ltd. | FMD Peripheral Guide Wire F-14 Flex 6; FMD Periphera… | |
| K253746 | 2026-03-19 | Lake Region Medical | Enroute 0.014'' Transcarotid Guidewire | |
| K253262 | 2026-03-06 | Nano4imaging GmbH | EmeryGlide (EG18008901) | |
| K253847 | 2026-01-31 | Merit Medical Ireland, Ltd. | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | |
| K251385 | 2026-01-21 | Merit Medical Ireland, Ltd. | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwir… | |
| K252674 | 2026-01-09 | Solo Pace, Inc. | Solo Pace Fusion System (SOLOFUSE1) | |
| K251596 | 2025-11-09 | William Cook Europe Aps | Lunderquist Extra Stiff Wire Guide | |
| K250203 | 2025-10-17 | Sureax Medical, LLC | SureAx-Guide | |
| K250031 | 2025-10-03 | ABBOTT MEDICAL | Amplatzer Guidewire | |
| K251181 | 2025-08-29 | Merit Medical Ireland, Ltd. | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5);… | |
| K250552 | 2025-07-25 | ABBOTT MEDICAL | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Com… | |
| K250075 | 2025-06-13 | Medtronic, Inc. | Medtronic Stedi Extra Support Guidewire | |
| K243733 | 2025-04-02 | Asahi Intecc Co., Ltd. | SION blue PLUS | |
| K241962 | 2025-03-27 | Asahi Intecc Co., Ltd. | Crossloop | |
| K242597 | 2025-03-05 | Asahi Intecc Co., Ltd. | CROSSLEAD 0.018inch | |
| K241702 | 2025-02-06 | Asahi Intecc Co., Ltd. | CROSSLEAD 0.014inch | FDA |
| K241521 | 2024-12-10 | Merit Medical Systems, Inc. | Prelude Small O.D. Introducer Guide Wire | |
| K242824 | 2024-12-06 | Lake Region Medical | PTFE Guidewire | FDA |
| K240818 | 2024-11-26 | Terumo Corporation | R2P Radifocus Glidewire Advantage | |
| K240997 | 2024-11-06 | ABBOTT MEDICAL | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Com… | |
| K241784 | 2024-09-18 | Teleflex Medical | Arrow® Nitinol Wire | |
| K240859 | 2024-08-21 | Terumo Corporation | Glidewire GT-R | |
| K241510 | 2024-08-14 | Asahi Intecc Co., Ltd. | CROSSLEAD Tracker | |
| K240387 | 2024-06-21 | Asahi Intecc Co., Ltd. | MINAMO blue; MINAMO viola | |
| K240460 | 2024-06-13 | FMD Co., Ltd. | FMD Peripheral Guide Wire F-18 Flex 400 (CSU41540025… | |
| K240864 | 2024-05-24 | Opsens, Inc. | PacePro Wire | |
| K232662 | 2024-05-14 | Biomerics Nle | BNLE Hydrophilic Jacketed Peripheral Guidewire | |
| K230418 | 2023-10-28 | Merit Medical Systems, Inc. | Mighty Wire Guide Wire | |
| K232570 | 2023-10-24 | Medtronic Vascular | Steerant Super Stiff Guidewire | |
| K232578 | 2023-10-11 | Filmec Co. , Ltd. | VASSALLO GT 018 G12; VASSALLO GT 018 G30 | |
| K232574 | 2023-10-11 | Filmec Co. , Ltd. | VASSALLO GT Crossing14 |
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。