FOZ
- 产品代码
- FOZ
- 器械名称
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5200
- FDA 专业组
- General Hospital
- 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)
- 507 件
该代码近三年的 510(k)（27 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260165 | 2026-08-10 | Spectrum Vascular | Unimpregnated Central Venous Catheter 摘要 |
| K261041 | 2026-07-10 | MedSource Labs, LLC | ClearSafe Closed System 摘要 |
| K260539 | 2026-07-09 | MedSource Labs, LLC | MedSource QuickSafe Safety IV Catheter; MedSource P 摘要 |
| K253235 | 2026-05-15 | B.Braun Medical, Inc. | Introcan Safety® Deep Access XL IV Catheter 摘要 |
| K252137 | 2026-04-02 | Becton Dickinson Infusion Therapy Syst | BD Insyte IV Catheter 摘要 |
| K252513 | 2026-04-01 | Poly Medicure Limited | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 摘要 |
| K252398 | 2025-12-17 | Terumo Medical Products (Hangzhou) Co. | SURFLO Hybria Closed System Safety IV Catheter 摘要 |
| K252677 | 2025-11-05 | Poly Medicure Limited | Polyshield Safety IV Catheters 摘要 |
| K251422 | 2025-10-08 | Becton Dickinson Infusion Therapy Syst | BD Saf-T-Intima Subcutaneous Catheter System 摘要 |
| K243403 | 2025-07-25 | Becton Dickinson Infusion Therapy Syst | BD Nexiva Closed IV Catheter System 摘要 |
| K251155 | 2025-07-11 | Becton Dickinson Infusion Therapy Syst | BD Cathena Safety IV Catheter 摘要 |
| K251654 | 2025-06-27 | Becton Dickinson Infusion Therapy Syst | BD Insyte Autoguard Shielded IV Catheter, BD Insyt 摘要 |
| K250682 | 2025-06-03 | Becton Dickinson Infusion Therapy Syst | BD Nexiva Diffusics Closed IV Catheter System and 摘要 |
| K243105 | 2025-05-16 | Venocare, Inc. | Ruby Intravascular Catheter 摘要 |
| K250292 | 2025-05-02 | Skydance Vascular, Inc. | OSPREY Midline Closed IV Catheter System (OspreyEDC 摘要 |
| K244059 | 2025-03-27 | Access Vascular, Inc. | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit 摘要 |
| K243599 | 2025-03-14 | Arrow International, LLC (A subsidiary | Arrow Endurance Extended Dwell Peripheral Catheter 摘要 |
| K242281 | 2024-12-20 | Arrow International, LLC (A subsidiary | Arrow Endurance Extended Dwell Peripheral Catheter S 摘要 |
| K241115 | 2024-11-27 | Spectrum Vascular | SV Spectrum MRC Central Venous Catheter; SV Spectrum 摘要 |
| K240359 | 2024-07-29 | Becton, Dickinson and Company (Bard Ac | PowerGlide Pro Midline Catheter 摘要 |
| K241845 | 2024-07-26 | B.Braun Medical, Inc. | Introcan Safety® 2 IV Catheter 摘要 |
| K233106 | 2024-04-19 | Bard Access Systems, Inc. (C.R. Bard, | AccuCath Ace Intravascular Catheter 摘要 |
| K232234 | 2024-03-15 | Poly Medicure Limited | Nouvo Safety Set 摘要 |
| K233529 | 2023-12-01 | Becton Dickinson Infusion Therapy Syst | BD Nexiva Diffusics Closed IV Catheter System with 摘要 |
| K231239 | 2023-09-22 | Becton Dickinson Infusion Therapy Syst | Nexiva Closed IV Catheter System with NearPort IV 摘要 |
| K231401 | 2023-09-21 | Poly Medicure Limited | Polysafety BC, Polysafety BC Adva, Polywin Safety, P 摘要 |
| K223788 | 2023-09-15 | Medsource International, LLC | The MedSource TrueSafe Blood Control I.V. Safety Cat 摘要 |
FDA 官方分类页： FOZ
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。