The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath I.v. Catheter.
| Device ID | K864038 |
| 510k Number | K864038 |
| Device Name: | SUPERCATH I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-16 |
| Decision Date | 1986-12-04 |