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FDA 510(k)

百合单次使用无菌胚胎移植导管

K号: K220010 · 2022-12-16

申请人Shanghai Horizon Medical Technology Co., Ltd.
决定日期2022-12-16
产品代码MQF
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决定实质等同

器械摘要

Daylily Single Use Sterile Embryo Transfer Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K220010. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Daylily Single Use Sterile Embryo Transfer Catheter?

Daylily Single Use Sterile Embryo Transfer Catheter is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Shanghai Horizon Medical Technology Co., Ltd.. The 510(k) number is K220010.

When did Daylily Single Use Sterile Embryo Transfer Catheter receive FDA 510(k) clearance?

Daylily Single Use Sterile Embryo Transfer Catheter received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220010.

Who is the listed applicant for Daylily Single Use Sterile Embryo Transfer Catheter?

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

What is the FDA product code for Daylily Single Use Sterile Embryo Transfer Catheter?

The FDA product code for Daylily Single Use Sterile Embryo Transfer Catheter is MQF.

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：MQF）

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。

K253354Minvitro 胚胎移植导管 (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)Guangzhou Hehong Biotech Co., Ltd.K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)Vitrolife Sweden ABK240307VitaVitro 胚胎移植导管（型号 ET-S、ET-SI、ET-A、ET-I、ET-IH）Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed 宫腔内人工授精Femasys, Inc.K200248Allwin胚胎移植导管（ETC），Allwin ETC型芯和软塞Allwin Medical Devices, Inc.K192540Kitazato ET 管套Kitazato Corporation

官方来源

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