FDA 510(k)

Vanguard IEP週邊氣球血管成形術系統，內建栓子防護功能

K 號：K181529 · 2018-12-06

決定日期2018-12-06

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, LLC. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K181529. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Contego Medical, LLC. The 510(k) number is K181529.

When did Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection receive FDA 510(k) clearance?

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection received FDA 510(k) clearance on 2018-12-06, under 510(k) number K181529.

Who is the listed applicant for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

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

What is the FDA product code for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

The FDA product code for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is LIT.

其他以 Contego Medical, LLC 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。

K181128Paladin 頸動脈後擴張氣球系統，內建栓子防護功能（Paladin 系統）

相關器械（代碼：LIT）

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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官方來源

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