FDA 510(k)

單環圈套回收套件，三環圈套回收套件

K 號：K191758 · 2019-12-17

決定日期2019-12-17

產品代碼MMX

諮詢委員會履歷

決定相當於

器材摘要

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K191758. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit?

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K191758.

When did Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit receive FDA 510(k) clearance?

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit received FDA 510(k) clearance on 2019-12-17, under 510(k) number K191758.

Who is the listed applicant for Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit?

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

What is the FDA product code for Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit?

The FDA product code for Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit is MMX.

其他以 Argon Medical Devices, Inc. 為申請人之記錄

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相關器械（代碼：MMX）

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。

K242776LimFlow V-CeiverLimFlow, Inc.K241259Amplatz鵝頸圈套組Medtronic, Inc.K232443單環圈套回收套件，三環圈套回收套件Argon Medical Devices, Inc.K222254蓮花Vena Cava Filter 取出組Cook Incorporated K222083LimFlow V-CeiverLimFlow, Inc.K212988ONORetrieval裝置Onocor Vascular, LLC

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