The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath5.
| Device ID | K140419 |
| 510k Number | K140419 |
| Device Name: | SUPERCATH5 |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TOGO MEDIKIT CO., LTD. 4-1-17 HONGO Bunkyo-ku, JP 113-0033 |
| Contact | Izumi Maruo |
| Correspondent | Izumi Maruo TOGO MEDIKIT CO., LTD. 4-1-17 HONGO Bunkyo-ku, JP 113-0033 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14543527243121 | K140419 | 000 |
| 74543527241624 | K140419 | 000 |
| 74543527241617 | K140419 | 000 |
| 74543527237221 | K140419 | 000 |
| 14543527237212 | K140419 | 000 |
| 74543527235388 | K140419 | 000 |
| 74543527235371 | K140419 | 000 |
| 14543527235362 | K140419 | 000 |
| 74543527235357 | K140419 | 000 |
| 14543527235348 | K140419 | 000 |
| 74543527235333 | K140419 | 000 |
| 74543527235326 | K140419 | 000 |
| 14543527235317 | K140419 | 000 |
| 14543527235300 | K140419 | 000 |
| 74543527235296 | K140419 | 000 |
| 74543527235289 | K140419 | 000 |
| 14543527235270 | K140419 | 000 |
| 74543527235265 | K140419 | 000 |
| 74543527241631 | K140419 | 000 |
| 74543527241648 | K140419 | 000 |
| 74543527243116 | K140419 | 000 |
| 74543527242652 | K140419 | 000 |
| 14543527242643 | K140419 | 000 |
| 14543527242636 | K140419 | 000 |
| 14543527242629 | K140419 | 000 |
| 14543527242612 | K140419 | 000 |
| 14543527242605 | K140419 | 000 |
| 14543527242599 | K140419 | 000 |
| 14543527242582 | K140419 | 000 |
| 14543527242575 | K140419 | 000 |
| 74543527242560 | K140419 | 000 |
| 74543527242553 | K140419 | 000 |
| 74543527242546 | K140419 | 000 |
| 14543527242537 | K140419 | 000 |
| 14543527242520 | K140419 | 000 |
| 74543527241662 | K140419 | 000 |
| 14543527241653 | K140419 | 000 |
| 74543527235258 | K140419 | 000 |