DXF
- 产品代码
- DXF
- 器械名称
- Catheter, Septostomy
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.5175
- 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)
- 21 件
该代码近三年的 510(k)（10 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261745 | 2026-06-26 | ElectroWire Medical | LightningWire Transseptal Puncture System (TPS) 摘要 |
| K253799 | 2026-03-13 | Pressure Products Medical Device Manuf | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R 摘要 |
| K260292 | 2026-02-27 | Atraverse Medical | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE 摘要 |
| K252419 | 2025-08-27 | Atraverse Medical, Inc. | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE 摘要 |
| K251007 | 2025-05-01 | Circa Scientific, Inc. | CrossWise RF Transseptal Access System (Models: CW-1 摘要 |
| K243193 | 2024-11-26 | Circa Scientific, Inc. | Cross Wise Multi-Use RF Adapter Cable 摘要 |
| K242076 | 2024-11-01 | Baylis Medical Company | VersaCross RF Wire 摘要 |
| K241414 | 2024-09-26 | Circa Scientific, Inc. | CrossWise RF Transseptal Access System (Models: CW-1 摘要 |
| K240900 | 2024-05-01 | Atraverse Medical | HOTWIRE RF Guidewire 摘要 |
| K232852 | 2023-10-12 | Cross Vascular, Inc. | Cross Vascular RF Transseptal Needle, Cross Vascular 摘要 |
FDA 官方分类页： DXF
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。