LJS
- 产品代码
- LJS
- 器械名称
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5970
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 14 件
- 其中 Summary 已存档
- 10 份，可直接下载
- FDA 历史累计 510(k)
- 302 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)（14 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260929 | 2026-04-17 | Navi Medical Technologies | Neonav ECG Tip Location System | |
| K252373 | 2025-12-16 | Spectrum Vascular | BioFlo Hybrid PICC with ENDEXO Technology and PASV V… | |
| K252792 | 2025-11-17 | Piccolo Medical, Inc. | PM2 System with ECGuide Connector | |
| K243458 | 2025-08-01 | Access Vascular, Inc. | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm g… | |
| K251212 | 2025-07-01 | Access Vascular, Inc. | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PIC… | |
| K243484 | 2025-05-29 | Piccolo Medical, Inc. | PM2+ System and SmartPICC Stylet | |
| K241587 | 2025-02-26 | Vygon Corporation | pilot TLS | |
| K241910 | 2025-01-19 | Navi Medical Technologies | Neonav ECG Tip Location System | |
| K243941 | 2025-01-17 | Access Vascular, Inc. | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm g… | |
| K240486 | 2024-09-08 | Piccolo Medical, Inc. | PM2 System and ECGuide Connector | |
| K233149 | 2023-12-01 | L&Z Us, Inc. | CATHTONG III Tapered PICC Catheter | — |
| K230669 | 2023-11-30 | Argon Medical Devices | L-Cath Single and Dual Lumen Catheters, L-Cath Mid… | FDA |
| K232594 | 2023-09-22 | L&Z Us, Inc. | CATHTONG II PICC Catheter | — |
| K232571 | 2023-09-22 | L&Z Us, Inc. | CATHTONG II PICC Catheter | — |
FDA 官方分类页： LJS
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。