SBK

Artificial Chordae Tendineae Surgical Replacement System

产品代码

SBK

器械名称

Artificial Chordae Tendineae Surgical Replacement System

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.3490

FDA 专业组

Cardiovascular

上市路径

需提交 510(k) 上市前通告

标记

属植入器械

标记

属生命支持/维持器械

该代码近三年的 510(k)

1 件

FDA 分类定义

An artificial chordae tendineae surgical replacement system is a standalone, prescription device consisting of nonabsorbable suture-based implant and suture placement device(s) that is used to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency. The device includes clips or fasteners to secure suture that are not embedded in the cardiac tissue. The system is used via surgical approach under direct visualization and not via transcatheter or percutaneous access.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2024-06-11。