The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath V.
| Device ID | K052267 |
| 510k Number | K052267 |
| Device Name: | SUPERCATH V |
| Classification | Needle, Fistula |
| Applicant | TOGO MEDIKIT CO., LTD. 4-2-1 YUSHIMA BUNKYO-KU Tokyo, JP 113-0034 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai TOGO MEDIKIT CO., LTD. 4-2-1 YUSHIMA BUNKYO-KU Tokyo, JP 113-0034 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-19 |
| Decision Date | 2006-10-27 |
| Summary: | summary |