Kitazato ET Catheter Type2-V5 EC-PRO Supported
The Kitazato ET Catheter Type2-v5 EC-PRO Supported is an embryo transfer catheter for ultrasound-guided placement of embryos into the uterine cavity after in vitro fertilization. This…
The Kitazato ET Catheter Type2-v5 EC-PRO Supported is an embryo transfer catheter for ultrasound-guided placement of embryos into the uterine cavity after in vitro fertilization. This configuration contains an 18 cm transfer catheter, used through the cervix to deliver embryos into the uterus.
The catheter has a polyurethane shaft with depth markings, a protective sleeve and a luer connector. A stainless steel outer stiffener supports the shaft. An attached syringe delivers the embryos through the catheter; the syringe is supplied separately.
Listed Item
4.7Fr 180mm EC-PRO Supported Inner Catheter
Configuration and Supply
Type2-v5 contains the transfer catheter without a guide catheter or trial catheter. It is supplied sterile following ethylene oxide sterilization and is intended for single use. The catheter has a 4.7 Fr outer diameter.
Who Else Makes It
Concentrated in Guangdong (4), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| UKS Medical Technology (Chongqing) Co., Ltd. | Chongging | Sichuan | Contract manufacturer | 4 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangzhou Hehong Biotech Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
Record
| Listed by | Kitazato Corporation, Japan |
|---|---|
| FDA product code | MQF |
| Device type | Catheter, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6110 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K162878 |
| Record published | 2019-02-07 |
| Record revised | 2023-08-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 205118 Type2-v5 EC-PRO Supported | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kitazato ET Catheter | Kitazato Corporation | 53 |
| Soft-Pass | Cook Incorporated | 21 |
| kitazato IUI Catheter | Kitazato Corporation | 20 |
| Soft-Trans | Cook Incorporated | 20 |
| Guardia | Cook Incorporated | 15 |
| Wallace | ICU Medical, Inc | 12 |
| Intrauterine insemination cannula | Gynetics Medical Products NV | 8 |
| Catheter, Assisted Reproduction | C R I | 8 |
| Minvitro Embryo Transfer Catheter | Guangzhou Hehong Biotech Co., Ltd. | 6 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 5 |
| Labotect | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | 5 |
| Microvol | Cook Incorporated | 5 |
Showing 12 of 111. All products under Catheter, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192540 | 2020-05-01 |
| K162878 | 2017-07-13 |
| K162667 | 2017-05-11 |
| K131491 | 2013-09-11 |
| K112396 | 2012-11-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.