FDA 510(k) Applications Submitted by Xi Han
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250732 |
03/11/2025 |
Disposable Endoscopy Valve Set |
Yangzhou Fartley Medical Instrument Technology Co,. Ltd |
| K130016 |
01/01/2013 |
LIFESPAN EPTFE VASCULAR GRAFT |
LEMAITRE VASCULAR, INC. |
| K120698 |
03/07/2012 |
GENESIS II PS NON-MODULAR FEMORAL COMPONENT |
SMITH & NEPHEW, INC. |
| K173323 |
10/20/2017 |
AnastoClip GC Closure System |
LeMaitre Vascular, Inc. |
| K143454 |
12/03/2014 |
Pruitt F3-S Carotid Shunt |
LeMaitre Vascular, Inc |
| K183513 |
12/18/2018 |
XenoSure Dura Biologic Patch |
LeMaitre Vascular Inc. |
| K142660 |
09/18/2014 |
Antegrade LeMills Valvulotome |
LeMaitre Vascular, Inc. |
| K192939 |
10/18/2019 |
Volumetric Specimen Imager |
Clarix Imaging |
| K210030 |
01/05/2021 |
Medical Surgical Mask |
Tianjin Aoshang Outdoor Equipment Co., Ltd. |
| K220442 |
02/16/2022 |
Synguard Nitrile Exam Glove |
Tianjin Aoshang Outdoor Equipment Co., Ltd. |
| K072458 |
08/31/2007 |
GBI TSH NEONATAL SCREENING KIT |
GOLDEN BRIDGE INTERNATIONAL, INC. |
| K241379 |
05/15/2024 |
Powered Wheelchair (NXN20-205, NXN20-205M) |
Zhejiang Nysin Medical Co., Ltd. |
| K221767 |
06/17/2022 |
Surgical Sutures with or without Needle |
Huaian Seamen Medical Technology Co., LTD |
| K223454 |
11/16/2022 |
Custom-made Invisible Aligners |
Zhejiang Yinchili Medical Technology Co., Ltd. |
| K211552 |
05/19/2021 |
Surgical mask |
Shandong Shengquan New Materials Co., Ltd. |
| K201514 |
06/08/2020 |
Child Face Mask |
Shandong Shengquan New Material Co., Ltd. |
| K201537 |
06/08/2020 |
Protective Face Mask for Medical Use |
Shandong Shengquan New Material Co., Ltd. |
| K201629 |
06/16/2020 |
Medical Face Mask |
Shandong Shengquan New Material Co., Ltd. |
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