NQG

Stabilizer, Heart, Non-Compression, Reprocessed

产品代码

NQG

器械名称

Stabilizer, Heart, Non-Compression, Reprocessed

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 870.4500

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)

3 件

FDA 分类定义

The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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）。