FDA 510(k)

Paladin 頸動脈後擴張氣球系統，內建栓子防護功能

K 號：K221339 · 2022-06-09

決定日期2022-06-09

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, Inc.. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K221339. 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 Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Contego Medical, Inc.. The 510(k) number is K221339.

When did Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection receive FDA 510(k) clearance?

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection received FDA 510(k) clearance on 2022-06-09, under 510(k) number K221339.

Who is the listed applicant for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?

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

What is the FDA product code for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?

The FDA product code for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is LIT.

其他以 Contego Medical, Inc. 為申請人之記錄

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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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