Data / Medical devices / Japan / Kitazato Corporation
Kitazato Corporation: FDA-registered device maker in Minato-ku Tokyo, Japan, 7 510(k) clearances
Kitazato Corporation is registered with the FDA (registration 3008456389) in Minato-ku Tokyo, Japan. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 1, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008456389
- Address
- 1-1-8 Shibadaimon, Minato-ku Tokyo, Japan, 105-0012
- Owner or operator
- Kitazato Corporation (10045322)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 5, 2013
- Registered through
- 2026
- Brand names listed
- Catheter 3Fr or 4Fr, Catheter 3Fr or 4Fr and Guide, Catheter 3Fr or 4Fr and Guide with Obturator, Catheter 4.7Fr Supported (EC-PRO Supported), Catheters 4.7Fr(EC-PRO), Echogenic Catheter 4.7Fr Supported (EC-PRO Master Supported), Echogenic Catheter 4.7Fr(EC-PRO Master), Echogenic Trial Catheter 4.7Fr Supported (Trial EC-PRO Master Supported) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Assisted Reproduction | MQF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Assisted Reproduction | MQE | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2020 | K192540 | Kitazato ET Catheters | MQF | Substantially Equivalent | Kitazato Corporation | accessdata.fda.gov |
| July 13, 2017 | K162878 | Kitazato ET Catheters | MQF | Substantially Equivalent | Kitazato Corporation | accessdata.fda.gov |
| July 11, 2017 | K162881 | Kitazato OPU Needles | MQE | Substantially Equivalent | Kitazato Corporation | accessdata.fda.gov |
| May 11, 2017 | K162667 | Kitazato IUI Catheter | MQF | Substantially Equivalent | Kitazato Corporation | accessdata.fda.gov |
| September 11, 2013 | K131491 | KITAZATO IUI CATHETER | MQF | Substantially Equivalent | Kitazato Medical Co., Ltd. | accessdata.fda.gov |
| November 26, 2012 | K112462 | KITAZATO OPU NEEDLE | MQE | Substantially Equivalent | Kitazato Medical Co., Ltd. | accessdata.fda.gov |
| November 2, 2012 | K112396 | IUI CATHETERS | MQF | Substantially Equivalent | Kitazato Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 1, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.