FDA 510(k)

Medline 硬脊膜外导管

K号: K150731 · 2016-03-07

决定日期2016-03-07

产品代码BSO

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决定实质等同

器械摘要

Medline Epidural Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-03-07 under 510(k) number K150731. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline Epidural Catheter?

Medline Epidural Catheter is a medical device that received FDA 510(k) clearance on 2016-03-07. The listed applicant is Medline Industries, Inc.. The 510(k) number is K150731.

When did Medline Epidural Catheter receive FDA 510(k) clearance?

Medline Epidural Catheter received FDA 510(k) clearance on 2016-03-07, under 510(k) number K150731.

Who is the listed applicant for Medline Epidural Catheter?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Epidural Catheter?

The FDA product code for Medline Epidural Catheter is BSO.

列明Medline Industries, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：BSO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX 球囊导管；Contiplex FX 球囊导管B.Braun Medical, Inc.K230603Arrow 非刺激型 SnapLock 适配器 (K-05520-005C)；Arrow 非刺激型下一代 SnapLock 适配器 (Luer 连接) (CA-000010-19)；Arrow 非刺激型下一代 SnapLock 适配器 (神经连接) (CA-000014-19)；Arrow 刺激型 SnapLock 适配器 (带电缆) (TZ-02060-001)；Arrow 刺激型 SnapLock 适配器 (带标签) (TZ-05000-002)Teleflex Medical K193664SubQKath 导管和针套装Hk Surgical K200624经皮引导器Epimed International, Inc.K191470C-CAT 麻醉导管套装Cimpax Aps

官方来源

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