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510(k) Data Aggregation
K Number
K220010Device Name
Daylily Single Use Sterile Embryo Transfer Catheter
Manufacturer
Shanghai Horizon Medical Technology Co., Ltd.
Date Cleared
2022-12-16
(346 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Horizon Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.
Device Description
Daylily Single Use Sterile Embryo Transfer Catheters are sterile single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. All models of the Daylily Single Use Sterile Embryo Transfer Catheters consist of a transfer catheter and a guide catheter. Some device models (Type II and Type IV) also include a trial catheter.
The guide catheter is composed of a catheter shaft, connector, and a positioning ring (for certain Type III and IV variants). Guide catheters for some Type III and Type IV variants are also provided pre-curved. Guide catheters have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.
The transfer catheter is composed of a catheter shaft, connector, and a stainless-steel sleeve (for Type III and IV models). Transfer catheters have a rounded/blunt tip and marker bands at the proximal end of the catheter to aid in catheter placement. The transfer catheter is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) connected to the connector of the transfer catheter is used to deliver the embryos into the uterine cavity.
The trial catheter is an optional accessory for specific models (Types II and IV), composed of a catheter shaft, connector, and a polymer-coated stainless-steel core. Trial catheters have a rounded/blunt closed tip. The trial catheter is used to provide additional support during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.
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