DQY
- 产品代码
- DQY
- 器械名称
- Catheter, Percutaneous
- 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
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 53 件
- 其中 Summary 已存档
- 48 份，可直接下载
- FDA 历史累计 510(k)
- 895 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)（53 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260559 | 2026-08-14 | IMDS Operation B.V. | NHanceIT | |
| K262392 | 2026-08-12 | Alembic, LLC | APRO 35 Swift Catheter | FDA |
| K261766 | 2026-07-29 | CenterPoint Systems, LLC | CPS Locator 3D Plus Delivery Catheter | |
| K262240 | 2026-07-29 | CenterPoint Systems, LLC | SSPC NXT Delivery Catheter | |
| K261825 | 2026-07-02 | Abbott | Amplatzer TorqVue LP Delivery System; Amplatzer Torq | |
| K261631 | 2026-06-17 | Abbott Medical | Amplatzer TorqVue Exchange System | |
| K260289 | 2026-06-05 | Balosmark, Inc. | Perfect-O Ostial Positioning Catheter | |
| K260993 | 2026-04-24 | Abbott | Amplatzer TorqVue Delivery System | |
| K253361 | 2026-04-10 | OrbusNeich Medical (Shenzhen) Co., Ltd | Teleport Glide Microcatheter | |
| K260499 | 2026-03-13 | ABBOTT MEDICAL | Amplatzer Trevisio Intravascular Delivery System; | FDA |
| K253409 | 2025-12-19 | Medtronic, Inc. | C320LBB Delivery System (C320LBBS45), C320LBB Delive | |
| K252417 | 2025-12-17 | ABBOTT MEDICAL | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | |
| K252390 | 2025-10-29 | Medtronic, Ireland | Telescope Guide Extension Catheter | |
| K250147 | 2025-08-22 | Centerpoint Systems | CPS Locator 3D Delivery Catheter | |
| K251277 | 2025-08-22 | Reflow Medical, Inc. | CoraForce Microcatheter, CoraFlex Microcatheter | |
| K250972 | 2025-06-29 | Pendracare | Primum Hydrophilic Guiding Catheter | |
| K250828 | 2025-06-27 | CenterPoint Systems, LLC | CPS Locator 3D Plus Delivery Catheter | |
| K243184 | 2025-06-25 | Strait Access Technologies Holdings | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | |
| K250492 | 2025-06-18 | CenterPoint Systems, LLC | FlexiGo 3D Delivery Catheter | FDA |
| K250219 | 2025-06-17 | Bard Peripheral Vascular, Inc. | Dorado PTA Balloon Dilatation Catheter | |
| K250410 | 2025-06-02 | W. L. Gore & Associates, Inc. | GORE® Tri-Lobe Balloon Catheter | |
| K243757 | 2025-05-02 | Shockwave Medical, Inc. | Shockwave CS Guide Catheter | |
| K251014 | 2025-05-01 | Alembic, LLC | APRO 45 Catheter | FDA |
| K250962 | 2025-04-29 | Alembic, LLC | APRO 55 Intermediate Catheter | |
| K250426 | 2025-04-25 | ABBOTT MEDICAL | Amulet Steerable Delivery Sheath | |
| K242337 | 2025-04-17 | Imds Operations B.V. | FlowGuide (FG60F); GuidionShort (GS60F) | |
| K243691 | 2025-04-04 | Seigla Medical, Inc. | LiquID .051 LP Guide Catheter Extension | |
| K250558 | 2025-03-27 | Medtronic, Inc. | SelectSite C304 Deflectable Catheter System (C304); | |
| K243436 | 2025-02-28 | Basis Medical | Seclusion Catheter | |
| K242873 | 2025-01-15 | Merit Medical Systems, Inc. | Ventrax Delivery System | |
| K242588 | 2025-01-07 | OrbusNeich Medical (Shenzhen) Co., Ltd | COREPASS Modular Microcatheter (FLEX); COREPASS Modu | |
| K243224 | 2024-12-31 | ABBOTT MEDICAL | MitraClip G5 Steerable Guide Catheter (SGC0801); Tr | |
| K242644 | 2024-12-20 | Okami Medical, Inc. | SENDERO MAX Delivery Catheter | |
| K240885 | 2024-12-19 | Simpson Interventions, Inc. | Shadow Catheter | |
| K243180 | 2024-12-04 | CenterPoint Systems, LLC | SSPC NXT Delivery Catheter | FDA |
| K242276 | 2024-09-30 | Vantis Vascular, Inc. | CrossFAST Integrated Microcatheter Guide Extension | |
| K240787 | 2024-09-12 | Biotronik, Inc. | Selectra 3D Lead Delivery System (443624-443629, 451 | |
| K241611 | 2024-09-03 | Imds Operations B.V. | ShapeIT (SI014135) | |
| K241538 | 2024-08-26 | ABBOTT MEDICAL | TriClip Steerable Guide Catheter | |
| K233637 | 2024-06-28 | Cordis US Corp | Cordis BRITECROSS Support Catheter | |
| K241158 | 2024-06-25 | Asahi Intecc Co., Ltd. | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI | |
| K241177 | 2024-05-28 | Micro Therapeutics Lnc. D/B/A Ev3 Neur | React 71 Catheter | |
| K234115 | 2024-03-15 | Alembic, LLC | APRO 55 Catheter | |
| K240384 | 2024-03-08 | Okami Medical, Inc. | SENDERO Microcatheter | |
| K233350 | 2024-02-08 | Reflow Medical, Inc. | SINC Support Catheter | |
| K240018 | 2024-02-01 | Boston Scientific Corporation | WATCHMAN TruSteer Access System (M635TU90050) | |
| K231608 | 2024-01-07 | OrbusNeich Medical (Shenzhen) Co., Ltd | Teleport XT Microcatheter | |
| K233858 | 2023-12-27 | Trisalus Life Sciences | TriSalus TriGuideTM Guiding Catheter | |
| K231600 | 2023-11-17 | Okami Medical, Inc. | SENDERO Microcatheter | |
| K231629 | 2023-10-31 | Eosolutions, Corp. | 091 Balloon Guide Catheter | |
| K232437 | 2023-10-13 | Wallaby Medical | Paragon 8F Balloon Guide Catheter | |
| K232647 | 2023-09-29 | Surmodics,Inc. | Microcatheter | |
| K232690 | 2023-09-29 | ABBOTT MEDICAL | Amulet Steerable Delivery Sheath |
FDA 官方分类页： DQY
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。