FDA 510(k)

止血敷料

K号: K213413 · 2023-09-01

申请人Jiangsu Newvalue Medical Products Co., Ltd.

决定日期2023-09-01

产品代码QSY

决定实质等同

器械摘要

Hemostatic Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Newvalue Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K213413. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the Hemostatic Dressing?

Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Jiangsu Newvalue Medical Products Co., Ltd.. The 510(k) number is K213413.

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

Hemostatic Dressing received FDA 510(k) clearance on 2023-09-01, under 510(k) number K213413.

Who is the listed applicant for Hemostatic Dressing?

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

What is the FDA product code for Hemostatic Dressing?

The FDA product code for Hemostatic Dressing is QSY.

列明Jiangsu Newvalue Medical Products Co., Ltd.为申报人的其他记录

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。

K202491一次性外科口罩

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 Limited K250319MFUSE (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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