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FDA 510(k)

超輔連續神經阻斷導管

K 號：K162522 · 2017-03-17

申請人Teleflexmedical, Inc.
決定日期2017-03-17
產品代碼BSO
諮詢委員會AN
決定相當於

器材摘要

UltraCath Continuous Nerve block Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K162522. 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 UltraCath Continuous Nerve block Catheter?

UltraCath Continuous Nerve block Catheter is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K162522.

When did UltraCath Continuous Nerve block Catheter receive FDA 510(k) clearance?

UltraCath Continuous Nerve block Catheter received FDA 510(k) clearance on 2017-03-17, under 510(k) number K162522.

Who is the listed applicant for UltraCath Continuous Nerve block Catheter?

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

What is the FDA product code for UltraCath Continuous Nerve block Catheter?

The FDA product code for UltraCath Continuous Nerve block Catheter is BSO.

相關臨床試驗

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其他以 Teleflexmedical, Inc. 為申請人之記錄

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。

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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 MedicalK193664SubQKath 穿刺針套組Hk SurgicalK200624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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