The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath 5.
| Device ID | K190001 |
| 510k Number | K190001 |
| Device Name: | Supercath 5 |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TOGO MEDIKIT Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City, JP 883-0062 |
| Contact | Daisuke Nagamizu |
| Correspondent | Izumi Maruo MIC International 4-1-17 Hongo Bunkyo-ku, JP 113-0033 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-02 |
| Decision Date | 2019-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14543527245729 | K190001 | 000 |
| 14543527242612 | K190001 | 000 |
| 14543527242605 | K190001 | 000 |
| 14543527242582 | K190001 | 000 |
| 14543527242575 | K190001 | 000 |
| 14543527242568 | K190001 | 000 |
| 14543527242551 | K190001 | 000 |
| 14543527241677 | K190001 | 000 |
| 14543527241653 | K190001 | 000 |
| 14543527241646 | K190001 | 000 |
| 14543527241639 | K190001 | 000 |
| 14543527241622 | K190001 | 000 |
| 14543527241615 | K190001 | 000 |
| 14543527251973 | K190001 | 000 |
| 84543527251965 | K190001 | 000 |
| 14543527242629 | K190001 | 000 |
| 14543527242636 | K190001 | 000 |
| 14543527245712 | K190001 | 000 |
| 14543527245705 | K190001 | 000 |
| 14543527237229 | K190001 | 000 |
| 14543527243121 | K190001 | 000 |
| 14543527243114 | K190001 | 000 |
| 14543527242643 | K190001 | 000 |
| 84543527245704 | K190001 | 000 |
| 14543527242650 | K190001 | 000 |
| 14543527242599 | K190001 | 000 |
| 14543527242544 | K190001 | 000 |
| 14543527242537 | K190001 | 000 |
| 14543527242520 | K190001 | 000 |
| 14543527241660 | K190001 | 000 |
| 14543527237212 | K190001 | 000 |
| 14543527238882 | K190001 | 000 |