The following data is part of a premarket notification filed by Kitazato Medical Co., Ltd. with the FDA for Kitazato Iui Catheter.
| Device ID | K131491 |
| 510k Number | K131491 |
| Device Name: | KITAZATO IUI CATHETER |
| Classification | Catheter, Assisted Reproduction |
| Applicant | KITAZATO MEDICAL CO., LTD. 816 CONGRESS AVE. STE. 1400 Austin, TX 78701 |
| Contact | Richard Vincins, Cba, Cqa, Rac |
| Correspondent | Richard Vincins, Cba, Cqa, Rac KITAZATO MEDICAL CO., LTD. 816 CONGRESS AVE. STE. 1400 Austin, TX 78701 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-23 |
| Decision Date | 2013-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14580303269180 | K131491 | 000 |
| 14580745041207 | K131491 | 000 |
| 04580745041217 | K131491 | 000 |
| 14580745041221 | K131491 | 000 |
| 04580745041231 | K131491 | 000 |
| 04580745041248 | K131491 | 000 |
| 14580745041252 | K131491 | 000 |
| 04580745041262 | K131491 | 000 |
| 14580745041276 | K131491 | 000 |
| 14580745041283 | K131491 | 000 |
| 14580303269074 | K131491 | 000 |
| 14580745041191 | K131491 | 000 |