The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath 6.
| Device ID | K160592 |
| 510k Number | K160592 |
| Device Name: | SUPERCATH 6 |
| 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 | 2016-03-01 |
| Decision Date | 2016-08-12 |
| Summary: | summary |