JXG
- 产品代码
- JXG
- 器械名称
- Shunt, Central Nervous System And Components
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.5550
- FDA 专业组
- Neurology
- 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
- 13 份，可直接下载
- FDA 历史累计 510(k)
- 259 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 |
|---|---|---|---|---|
| K261004 | 2026-06-23 | Integra Lifesciences Production Corpor… | Codman® Distal Peritoneal Catheter, Barium Open End … | |
| K251598 | 2025-12-10 | Brainspace, Inc. | Intellidrop | |
| K250636 | 2025-11-28 | Sophysa | Sophy Mini Monopressure Valve (SM1) | |
| K252514 | 2025-11-05 | Phasor Health, LLC | EVAC-MRI | |
| K243531 | 2025-08-08 | Integra Lifesciences Production Corpor… | Codman Libertís Shunt Catheter with Bactiseal and En… | |
| K243552 | 2025-08-06 | Integra Lifesciences Production Corpor… | Codman Libertís 1.5 mm EVD Catheter with Bactiseal®… | |
| K242974 | 2025-06-20 | Sophysa | External CSF Drainage Ventricular Catheters, Externa… | |
| K243205 | 2025-06-03 | Phasor Health, LLC | EVAC | |
| K243676 | 2025-03-10 | Medtronic Neurosurgery | Duet External Drainage and Monitoring System (EDMS) | |
| K242003 | 2024-12-16 | Aesculap, Inc. | XABO Ventricular Catheter, XABO Peritoneal Catheter,… | |
| K241458 | 2024-08-20 | Borvo Medical, Inc. | Borvo EVAC System (Ergo); Borvo EVAC System (Classic… | FDA |
| K233445 | 2024-01-17 | Integra Lifesciences Production Corpor… | Bactiseal Catheters; Bactiseal Barium Striped Cathet… | |
| K233448 | 2023-12-19 | Integra Lifesciences Production Corpor… | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Cat… | |
| K231664 | 2023-10-19 | Irras USA, Inc. | IRRAflow Active Fluid Exchange System (AFES) |
FDA 官方分类页： JXG
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。