FDA 510(k)

Medline 加强型硬脊膜外导管

K号: K181782 · 2019-03-04

决定日期2019-03-04

产品代码BSO

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决定实质等同

器械摘要

Medline Reinforced 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 2019-03-04 under 510(k) number K181782. 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 Reinforced Epidural Catheter?

Medline Reinforced Epidural Catheter is a medical device that received FDA 510(k) clearance on 2019-03-04. The listed applicant is Medline Industries, Inc.. The 510(k) number is K181782.

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

Medline Reinforced Epidural Catheter received FDA 510(k) clearance on 2019-03-04, under 510(k) number K181782.

Who is the listed applicant for Medline Reinforced 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 Reinforced Epidural Catheter?

The FDA product code for Medline Reinforced 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。

K230559Hudson RCI® 4 PSI 压力释放阀的 disposable 加湿器（3230），Hudson RCI® 6 PSI 压力释放阀的 disposable 加湿器（3260）K223100Hudson RCI AquaTherm III Plus 外部可调电子加热器（050-14）K222665Medline UNITE® 踝关节融合接骨板系统 K213054Medline Sure-Snap安全注射针，Medline Sure-Snap安全注射器 K212911Konig Mogen 夹 K220565Hudson RCI Triflo II 激励深呼吸训练器

查看所有 74 个设备 →

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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