FDA 510(k)

QuikClot Control+ 體內止血設備

K 號：K243553 · 2025-03-18

決定日期2025-03-18

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 Device is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K243553. 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 Device?

QuikClot Control+ Hemostatic Device is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Teleflex Medical. The 510(k) number is K243553.

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

QuikClot Control+ Hemostatic Device received FDA 510(k) clearance on 2025-03-18, under 510(k) number K243553.

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

FDA 510(k) 記錄將Teleflex Medical列為申請人。這並不單獨確立設備製造商的身份。

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

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

其他以 Teleflex Medical 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。

K261418Liquick X-treme, Liquick X-treme Plus K251054Hem-o-lok™ 紫色加™ 大型聚合物結合夾 K242495LMA Fastrach ETT SU K241784Arrow® Nitinol Wire K233713Pilling 氣管切開管 K232970Hem-o-lok® 鎖定夾

查看所有 21 項裝置 →

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。

K213198Ax-Surgi 外科止血钳Advamedica, Inc.K220971QuikClot Control+ 止血敷料Z-Medica, LLC K200167QuikClot Control+Z-Medica, LLC K183190NuStatBeeken Biomedical, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。