The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath 5.
| Device ID | K081953 |
| 510k Number | K081953 |
| Device Name: | SUPERCATH 5 |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-09 |
| Decision Date | 2009-03-12 |
| Summary: | summary |