FDA 510(k)

美林強化硬脊膜外針管

K 號：K181782 · 2019-03-04

決定日期2019-03-04

產品代碼BSO

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Medline Industries, Inc. 為申請人之記錄

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相關器械（代碼：BSO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241410EDEN控制心臟导管Jmt Co., Ltd.K231242Perifix FX 管針；Contiplex FX 管針B.Braun Medical, Inc.K230603Arrow 非刺激型 SnapLock 适配器 (K-05520-005C)；Arrow 非刺激型 Next Gen SnapLock 适配器 (Luer 連接) (CA-000010-19)；Arrow 非刺激型 Next Gen SnapLock 适配器 (神經根連接) (CA-000014-19)；Arrow 刺激型 SnapLock 适配器 (帶電纜) (TZ-02060-001)；Arrow 刺激型 SnapLock 适配器 (帶卡扣) (TZ-05000-002)Teleflex Medical K193664SubQKath 穿刺針套組Hk Surgical K200624經皮導入器Epimed International, Inc.K191470C-CAT 麻醉針管組套Cimpax Aps

官方來源

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