FDA 510(k)

InFrame™ 穿刺固定系統

K 號：K201430 · 2020-06-20

決定日期2020-06-20

產品代碼HWC

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決定相當於

器材摘要

InFrame™ Cannulated Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Exsomed Corp.. It received FDA 510(k) clearance on 2020-06-20 under 510(k) number K201430. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the InFrame™ Cannulated Fixation System?

InFrame™ Cannulated Fixation System is a medical device that received FDA 510(k) clearance on 2020-06-20. The listed applicant is Exsomed Corp.. The 510(k) number is K201430.

When did InFrame™ Cannulated Fixation System receive FDA 510(k) clearance?

InFrame™ Cannulated Fixation System received FDA 510(k) clearance on 2020-06-20, under 510(k) number K201430.

Who is the listed applicant for InFrame™ Cannulated Fixation System?

The FDA 510(k) record lists Exsomed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InFrame™ Cannulated Fixation System?

The FDA product code for InFrame™ Cannulated Fixation System is HWC. This falls under the Cardiovascular category.

其他以 Exsomed Corp. 為申請人之記錄

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相關器械（代碼：HWC）

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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