The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath A.v. Fistula.
| Device ID | K854773 |
| 510k Number | K854773 |
| Device Name: | SUPERCATH A.V. FISTULA |
| Classification | Needle, Fistula |
| Applicant | TOGO MEDIKIT CO., LTD. SHOEI-SURVGADAI BLDG 1-2 KANDA-SURUGADAI 3 CHOME Chiyoda-ku Tokyo101 Japan, JP |
| Contact | Hiroaki Nakajima |
| Correspondent | Hiroaki Nakajima TOGO MEDIKIT CO., LTD. SHOEI-SURVGADAI BLDG 1-2 KANDA-SURUGADAI 3 CHOME Chiyoda-ku Tokyo101 Japan, JP |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-29 |
| Decision Date | 1986-04-08 |