FDA 510(k) Applications Submitted by Wen Gu

FDA 510(k) Number	Submission Date	Device Name	Applicant
K242756	09/12/2024	Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070	Pulnovo Medical (Wuxi) Co., Ltd
K170279	01/30/2017	Disposable High Pressure Syringe	Union Medical Shenzhen Co., Ltd.