The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath 5 Model Sp120-xx-xx, Sp125-xx-xx.
| Device ID | K093546 |
| 510k Number | K093546 |
| Device Name: | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TOGO MEDIKIT CO., LTD. 4-1-17 HONGO, BUNKYO-KU Tokyo, JP 113-0033 |
| Contact | Fumiaki Kanai, Ph.d |
| Correspondent | Fumiaki Kanai, Ph.d TOGO MEDIKIT CO., LTD. 4-1-17 HONGO, BUNKYO-KU Tokyo, JP 113-0033 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2009-12-17 |
| Summary: | summary |