Kitazato IUI Catheter
Kitazato IUI Catheter delivers sperm into the uterine cavity through the cervix. It has a rounded tip with two side holes, an outer stiffener and a proximal connector for a separate…
Kitazato IUI Catheter delivers sperm into the uterine cavity through the cervix. It has a rounded tip with two side holes, an outer stiffener and a proximal connector for a separate syringe.
Type 4 catheters have no integral stainless-steel core and may use a separate stylet cannula for support. Type 5 catheters contain a stainless-steel core to help maintain shaft shape.
Listed Item
Catheter with Outer Stiffener with Stainless Steel Core, 10cm, model number Type5-v4
Catheter Construction
The catheter shaft is PVC with an ABS connector. Configurations include 10 or 18 cm shafts and depth markings at 5, 6, 7 and 8 cm from the tip. The separate stainless-steel stylet can add rigidity to Type 4 during passage through a sharply curved cervix.
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) | K162667 |
| Record published | 2018-01-25 |
| Record revised | 2023-08-07 (version 8) |
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 50, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 140198 Type6-v2 | In distribution | |
| 131114 | In distribution | |
| 131111 | In distribution | |
| 131184 Type4-v1 | In distribution | |
| 131191 | In distribution | |
| 131196 | In distribution | |
| 140118 Type6-v1 | In distribution | |
| 131106 Type5-v4 | In distribution | |
| 131104 Type4-v3 | In distribution | |
| 131102 Type4-v4 | In distribution | |
| 131186 Type5-v2 | In distribution | |
| 140128 | In distribution | |
| 131182 Type4-v2 | In distribution | |
| 131181 Type5-v1 | In distribution | |
| 131194 | In distribution | |
| 140208 | In distribution | |
| 131192 | In distribution | |
| 131112 | In distribution | |
| 131116 | In distribution | |
| 131101 Type5-v3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kitazato ET Catheter | Kitazato Corporation | 53 |
| Soft-Pass | Cook Incorporated | 21 |
| 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 |
| Tefcat | Cook Incorporated | 4 |
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.