FDA 510(k)

QuikClot Control+ 止血敷料

K 號：K220971 · 2022-12-14

決定日期2022-12-14

產品代碼POD

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

QuikClot Control+ Hemostatic Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Z-Medica, LLC. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K220971. The device is classified under product code POD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QuikClot Control+ Hemostatic Dressing?

QuikClot Control+ Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Z-Medica, LLC. The 510(k) number is K220971.

When did QuikClot Control+ Hemostatic Dressing receive FDA 510(k) clearance?

QuikClot Control+ Hemostatic Dressing received FDA 510(k) clearance on 2022-12-14, under 510(k) number K220971.

Who is the listed applicant for QuikClot Control+ Hemostatic Dressing?

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

What is the FDA product code for QuikClot Control+ Hemostatic Dressing?

The FDA product code for QuikClot Control+ Hemostatic Dressing is POD.

其他以 Z-Medica, 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。

K200167QuikClot Control+K181641快克洛 Radial

相關器械（代碼：POD）

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。

K243553QuikClot Control+ 體內止血設備Teleflex Medical K213198Ax-Surgi 外科止血钳Advamedica, Inc.K200167QuikClot Control+Z-Medica, LLC K183190NuStatBeeken Biomedical, LLC

官方來源

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