NRY
- 产品代码
- NRY
- 器械名称
- Catheter, Thrombus Retriever
- 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
- 该代码近三年的 510(k)
- 114 件
FDA 分类定义
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
该代码近三年的 510(k)（36 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260617 | 2026-08-28 | Rapid Medical Ltd. | Tigertriever 13 Ultra Revascularization Device | |
| K262398 | 2026-08-13 | CERENOVUS, Inc. | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspira | |
| K262399 | 2026-08-12 | Perfuze, Ltd. | Millipede System | |
| K262391 | 2026-08-12 | Alembic, LLC | APRO 35 Swift Catheter and Alembic Aspiration Tubing | FDA |
| K260002 | 2026-07-16 | Scientia Vascular, Inc. | Socrates Aspiration System (Socrates 70 Aspiration C | |
| K250690 | 2026-06-10 | Penumbra, Inc. | Penumbra System (Thunderbolt Aspiration Tubing) | |
| K252707 | 2026-05-20 | Suzhou Zenith Vascular SciTech Limited | Zenith Aspiration Catheter; Disposable Aspiration Tu | |
| K254276 | 2026-05-07 | QApel Medical, Inc. | Lynx Aspiration Catheter System | |
| K253590 | 2026-03-16 | Perfuze, Ltd. | Millipede System | |
| K253062 | 2026-03-12 | Rapid Medical Ltd. | Tigertriever 25 Revascularization Device | |
| K251357 | 2026-01-15 | Phenox, Ltd. | Esperance pHLO Aspiration System | |
| K251006 | 2025-11-10 | Vesalio, Inc. | NeVasc Aspiration System | |
| K252046 | 2025-10-30 | Imperative Care, Inc. | Zoom System (Zoom 4S Catheter) | |
| K251603 | 2025-10-06 | Rapid Medical Ltd. | Tigertriever 17 Ultra Revascularization Device | |
| K251789 | 2025-09-25 | Neuravi Limited | EMBOTRAP III Revascularization Device | |
| K252392 | 2025-08-29 | Perfuze, Ltd. | Millipede70 Aspiration Catheter; Perfuze Aspiration | |
| K251828 | 2025-08-22 | Cerenovus, Inc. | CEREGLIDE 71 Catheter System; Cerenovus Aspiration T | |
| K243948 | 2025-06-03 | Balt USA, LLC | Raptor Aspiration Catheter; Balt Aspiration Tubing S | |
| K243047 | 2025-05-28 | Imperative Care, Inc. | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD A | |
| K243601 | 2025-05-19 | Route 92 Medical, Inc. | Route 92 Medical HiPoint Reperfusion System and Aspi | |
| K251015 | 2025-04-30 | Alembic, LLC | APRO 45 Catheter and Alembic Aspiration Tubing | |
| K250958 | 2025-04-28 | Alembic, LLC | APRO 55 Swift Catheter and Alembic Aspiration Tubing | |
| K250012 | 2025-02-26 | Perfuze, Ltd. | Millipede 070 Aspiration Catheter; Perfuze Aspiratio | |
| K243287 | 2025-02-24 | Alembic, LLC | APRO 70 Swift Catheter and Alembic Aspiration Tubing | |
| K242104 | 2025-02-13 | Penumbra, Inc. | Penumbra System (Reperfusion Catheter RED 72) | |
| K242672 | 2025-01-14 | Imperative Care, Inc. | Zoom System | |
| K243080 | 2024-10-29 | Micro Therapeutics, Inc. d/b/a ev3 Neu | Riptide Aspiration System | |
| K241221 | 2024-10-16 | Cerenovus, Inc. | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Int | |
| K240917 | 2024-10-01 | Wallaby Medical | Esperance 3+ Aspiration Catheter System | |
| K242504 | 2024-09-20 | Perfuze, Ltd. | Millipede 088 Access Catheter; Millipede 070 Aspirat | FDA |
| K234083 | 2024-07-02 | Balt USA, LLC | Next Generation Aspiration Catheter; Balt Aspiration | |
| K233329 | 2024-04-23 | Route 92 Medical, Inc. | Route 92 Medical Full Length 054 Reperfusion System | |
| K232971 | 2024-02-29 | Alembic, LLC | APRO 55 Catheter and Alembic Aspiration Tubing | |
| K233988 | 2024-01-17 | Cerenovus, Inc. | Cerenovus Large Bore Catheter; Cerenovus Aspiration | |
| K232524 | 2023-10-18 | Perfuze, Ltd. | Millipede 070 Aspiration Catheter; Perfuze Aspiratio | |
| K223913 | 2023-09-20 | Scientia Vascular, Inc. | Socrates Aspiration System |
FDA 官方分类页： NRY
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。