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510(k) Data Aggregation
(128 days)
The RELIEEV HSG Catheter (HSG7FA1) is for the delivery of contrast media or saline into the uterine cavity during hysterosalpingography or sonohysterography for examination of the uterus and fallopian tubes.
The RELIEEV HSG Catheter (HSG7FA1) is a 7 French (Fr) dual lumen polyurethane catheter with a working length of 30 cm. RELIEEV HSG Catheter (HSG7FA1) is available with a closed-end tip with two side ports. The catheter consists of two lumens: an open lumen used to inflate the balloon and an open lumen used to inject diagnostic media into the uterus. The silicone balloon is designed with a balloon volume of 3.5 mL. When the balloon is inflated inside the uterus, the subject device seals the cervix. The catheter features a proximal fitting of a double-lumen polyurethane hub with a polycarbonate stopcock attached. Both the hub and stopcock accept a standard Luer lock. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. An introducing sheath is placed over the tube as a guide and into the endocervix to the level of the internal os (opening of the cervix) with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity.
The RELIEEV HSG Catheter (HSG7FA1) consists of a balloon catheter and a 5 mL syringe. The subject device is supplied sterile and is single-use.
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