FDA 510(k)

流暢充氣設備

K 號：K162272 · 2016-10-20

決定日期2016-10-20

產品代碼MAV

諮詢委員會履歷

決定相當於

器材摘要

Fluent inflation device is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K162272. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fluent inflation device?

Fluent inflation device is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K162272.

When did Fluent inflation device receive FDA 510(k) clearance?

Fluent inflation device received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162272.

Who is the listed applicant for Fluent inflation device?

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

What is the FDA product code for Fluent inflation device?

The FDA product code for Fluent inflation device is MAV.

其他以 Vascular Solutions, 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：MAV）

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。

K260035數位無限擴張器 INFLANTEUAB Telemedicina K220773埃佛勒斯20充氣設備及三通閥門（AC2200）；埃佛勒斯30充氣設備及三通閥門（AC3200）；埃佛勒斯20生存套件，內含：1. 埃佛勒斯20設備配三通閥門，2. 皮頓Y型接頭，3. 金屬導絲針插入針，4. 扭力把手（AC2205P）；埃佛勒斯30生存套件，內含：1. 埃佛勒斯30設備配三通閥門，2. 皮頓Y型接頭，3. 金屬導絲針插入針，4. 扭力把手（AC3205P）Medtronic Vascular K153038埃佛勒斯20一次性充氣設備，埃佛勒斯20生存套件，埃佛勒斯30一次性充氣設備，埃佛勒斯30生存套件Medtronic, Inc.K153672basixTOUCH40 膨脹針筒Merit Medical Systems, Inc.

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