The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Kitazato Et Catheters.
| Device ID | K192540 |
| 510k Number | K192540 |
| Device Name: | Kitazato ET Catheters |
| Classification | Catheter, Assisted Reproduction |
| Applicant | Kitazato Corporation Shibakoen Building, 1-1-8 Shibadaimon, Minato-ku Tokyo, JP 105-0012 |
| Contact | Futoshi Inoue |
| Correspondent | Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Ste 300 Austin, TX 78746 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2020-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14580303266141 | K192540 | 000 |