FDA 510(k)

VitaVitro 胚胎移植針管（型號 ET-S、ET-SI、ET-A、ET-I、ET-IH）

K 號：K240307 · 2024-08-16

決定日期2024-08-16

產品代碼MQF

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240307. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)?

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K240307.

When did VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) receive FDA 510(k) clearance?

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240307.

Who is the listed applicant for VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)?

The FDA 510(k) record lists Shenzhen Vitavitro Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)?

The FDA product code for VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) is MQF.

其他以 Shenzhen Vitavitro Biotech Co., Ltd. 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。

K240523VitaVitro®單腔卵母細胞採集針（ORNS-17G、ORNS-18G），VitaVitro®雙腔卵母細胞採集針（ORND-17G）K212410VitaVitro 精子洗滌劑，VitaVitro 精子濾層劑 K200408VitaVitro® 繁殖培養基，VitaVitro® 精子緩冲培養基，VitaVitro® 淨化緩冲培養基 K1910631-步驟培養基質

相關器械（代碼：MQF）

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。

K253354Minitro胚胎移植針管（ETCA23175、ETCA23175-C、ETCB20175、ETCB20175-C、ETCB20175-ET、ETCB20175-ET-C）Guangzhou Hehong Biotech Co., Ltd.K243373胚胎移植針管組合：EmbryoCath 胚胎移植針管 - 預曲 230 mm (參考編號 17500)；EmbryoCath 胚胎移植針管 - 直型可塑 180 mm (參考編號 17501)；EmbryoCath 胚胎移植針管 - 直型可塑 230 mm (參考編號 17502)；EmbryoCath 射針 - 180 mm (參考編號 17510)；EmbryoCath 射針 - 230 mm (參考編號 17511)Vitrolife Sweden AB K231730FemaSeed 鼓室內射精器Femasys, Inc.K220010百合單次使用无菌胚胎移植針管Shanghai Horizon Medical Technology Co., Ltd.K200248Allwin胚胎移植針（ETC），Allwin ETC針芯和柔軟塞子Allwin Medical Devices, Inc.K192540北澤田ET心导管Kitazato Corporation

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