The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath Z3v.
| Device ID | K050114 |
| 510k Number | K050114 |
| Device Name: | SUPERCATH Z3V |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TOGO MEDIKIT CO., LTD. 17148-6 AZA KAMEKAWA OAZA HICHIYA Hyuga City, Miyazaki Pref., JP 883-0062 |
| Contact | Kozo Nagayamab |
| Correspondent | Kozo Nagayamab TOGO MEDIKIT CO., LTD. 17148-6 AZA KAMEKAWA OAZA HICHIYA Hyuga City, Miyazaki Pref., JP 883-0062 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-06-09 |
| Summary: | summary |