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FDA 510(k)

StatGuard止血贴，StatGuard止血敷料

K号: K172155 · 2018-04-12

申请人Statguard, LLC
决定日期2018-04-12
产品代码QSY
决定实质等同

器械摘要

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Statguard, LLC. It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K172155. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing?

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Statguard, LLC. The 510(k) number is K172155.

When did StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing receive FDA 510(k) clearance?

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing received FDA 510(k) clearance on 2018-04-12, under 510(k) number K172155.

Who is the listed applicant for StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing?

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

What is the FDA product code for StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing?

The FDA product code for StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing is QSY.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：QSY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm直径（FG100300）；Ganymede 5cm x 5cm（FG100400）；Ganymede 10cm x 10cm（FG100500）；Ganymede 15cm x 15cm（FG100600）；Ganymede 20cm x 30cm（FG100700）；Ganymede 25cm x 25cm（FG100800）；Ganymede 30cm x 30cm（FG100900）；Ganymede 40cm x 40cm （FG100999）；Ganymede 7.5cm x 120cm（FG100100）；Ganymede-X 2cm直径（FG100301）；Ganymede-X 5cm x 5cm（FG100401）；Ganymede-X 10cm x 10cm（FG100501）；Ganymede-X 15cm x 15cm（FG100601）；Ganymede-X 20cm x 30cm （FG100701）；Ganymede-X 25cmSpeciality Fibres and Materials LimitedK250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 止血凝胶Cresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097多糖止血粉（HP-2，HP-3，HP-5）Ushare Medical, Inc.

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