The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath Z3v.
| Device ID | K112290 |
| 510k Number | K112290 |
| Device Name: | SUPERCATH Z3V |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TOGO MEDIKIT CO., LTD. 4-1-17 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai TOGO MEDIKIT CO., LTD. 4-1-17 HONGO Bunkyo-ku, Tokyo, 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 | 2011-08-09 |
| Decision Date | 2012-04-16 |
| Summary: | summary |