FDA 510(k)

ClearPetra 吸排式套管

K 號：K203119 · 2020-12-09

決定日期2020-12-09

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

ClearPetra Suction-Evacuation Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-09 under 510(k) number K203119. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ClearPetra Suction-Evacuation Sheath?

ClearPetra Suction-Evacuation Sheath is a medical device that received FDA 510(k) clearance on 2020-12-09. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K203119.

When did ClearPetra Suction-Evacuation Sheath receive FDA 510(k) clearance?

ClearPetra Suction-Evacuation Sheath received FDA 510(k) clearance on 2020-12-09, under 510(k) number K203119.

Who is the listed applicant for ClearPetra Suction-Evacuation Sheath?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPetra Suction-Evacuation Sheath?

The FDA product code for ClearPetra Suction-Evacuation Sheath is FED.

其他以 Well Lead Medical Co., Ltd. 為申請人之記錄

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相關器械（代碼：FED）

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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