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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K220010
Device Name Daylily Single Use Sterile Embryo Transfer Catheter
Applicant
Shanghai Horizon Medical Technology Co., Ltd.
Rm. 401, Bldg. 24, # 1-28, 588 Tianxiong Rd.
Pudong New Area
Shanghai,  CN 201318
Applicant Contact Beibei Xing
Correspondent
Microport Group Co., Ltd.
1601 Zhangdong Rd., Zj Hi-Tech Park
Pudong New District
Shanghai,  CN 201203
Correspondent Contact Zhixuan Zhang
Regulation Number884.6110
Classification Product Code
MQF  
Date Received01/04/2022
Decision Date 12/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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