The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath 5 (26g).
| Device ID | K172496 |
| 510k Number | K172496 |
| Device Name: | SUPERCATH 5 (26G) |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TOGO Medikit Co., Ltd. 17148-6 Aza Kamekawa Oaza Hichiya Hyuga City, JP 883-0062 |
| Contact | Daisuke Nagamizu |
| Correspondent | Daisuke Nagamizu TOGO Medikit Co., Ltd. 17148-6 Aza Kamekawa Oaza Hichiya Hyuga City, JP 883-0062 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-18 |
| Decision Date | 2018-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14543527241677 | K172496 | 000 |