FDA 510(k)

Heli-FX內視鏡固定系統

K 號：K182957 · 2018-11-21

決定日期2018-11-21

產品代碼OTD

諮詢委員會履歷

決定相當於

器材摘要

Heli-FX EndoAnchor System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182957. The device is classified under product code OTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Heli-FX EndoAnchor System?

Heli-FX EndoAnchor System is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K182957.

When did Heli-FX EndoAnchor System receive FDA 510(k) clearance?

Heli-FX EndoAnchor System received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182957.

Who is the listed applicant for Heli-FX EndoAnchor System?

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

What is the FDA product code for Heli-FX EndoAnchor System?

The FDA product code for Heli-FX EndoAnchor System is OTD.

其他以 Medtronic Vascular, 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。

K171866Sentrant 引導鞘，具有親水塗層 K170191銀鷹周邊斑塊切除系統，超鷹周邊斑塊切除系統 K171427Heli-FX 滴劑器，Heli-FX 引導器，輔助內科Anchor卡匣 K161361HawkOne 定向動脈內切除系統

相關器械（代碼：OTD）

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。

K171427Heli-FX 滴劑器，Heli-FX 引導器，輔助內科Anchor卡匣Medtronic Vascular, Inc.

官方來源

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